ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
Sponsor
Edwards Lifesciences (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT01757665
Collaborator
(none)
777
32
1
164
24.3
0.1
Study Details
Study Description
Brief Summary
The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their native or prosthetic aortic or mitral valve.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Multicenter, prospective, single arm trial - Up to seven hundred (700) aortic valve replacement (AVR) subjects and up to one hundred seventy-five (175) mitral valve replacement (MVR) subjects at up to forty (40) clinical sites will be enrolled. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valve. Patients will be followed and assessed after implant for up to 5 years.
Study Design
Study Type:
Interventional
Actual Enrollment
:
777 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Aortic and Mitral Bioprostheses (Models 11000A and 11000M) With a New Tissue Treatment Platform (COMMENCE)
Study Start Date
:
Dec 1, 2012
Actual Primary Completion Date
:
Aug 1, 2017
Anticipated Study Completion Date
:
Aug 1, 2026
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000M Aortic/Mitral valve replacement therapy |
Device: Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
Implant of an aortic valve, Model 11000A or mitral valve, Model 11000M
|
Outcome Measures
Primary Outcome Measures
- Subjects With Structural Valve Deterioration [1 Year Post Implant]
The rate of implanted subjects that experience structural valve deterioration (SVD) of the trial valve by the time of the post operative day (POD) 390 follow-up visit. Structural valve deterioration includes dysfunction or deterioration intrinsic to the valve. Examples of SVD includes complications such as wear, fracture, calcification, leaflet tear.
Secondary Outcome Measures
- Percentage of Subjects With Early Adverse Events [Events occuring within 30 days of procedure]
Number of subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100
- Percentage of Late Adverse Events Divided by Late Patient Years [Events occurring >= 31 days and up through 3 years post-implant]
Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
Other Outcome Measures
- Subject's Average Mean Gradient Measurements - 11000A [3 Months, 1 Year, and 2 Year Post Implant]
Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.
- Subject's Average Mean Gradient Measurements - 11000M [3 Months, 1 Year, and 2 Years Post Implant]
Mean gradient is the average flow of blood through the mitral valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.
- Subject's Average Peak Gradients Measurements Over Time - 11000A [3 Months, 1 Year, and 2 Years Post Implant]
Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.
- Subject's Average Peak Gradients Measurements Over Time - 11000M [3 Months, 1 Year, and 2 Years Post Implant]
Peak gradient is the maximum value measured of flow of blood through the mitral valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.
- Subject's Average Effective Orifice Area Measurements - 11000A [3 Months, 1 Year, and 2 Years Post Implant]
Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.
- Subject's Average Effective Orifice Area Measurements - 11000M [3 Months, 1 Year, and 2 Years Post Implant]
Effective orifice area represents the cross-sectional area of the blood flow downstream of the mitral valve. Effective orifice area is evaluated by echocardiography over time.
- Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A [3 Months, 1 Year, and 2 Years Post Implant]
Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.
- Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M [3 Months, 1 Year, and 2 Years Post Implant]
Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.
- Subject's Average Performance Index Measurements - 11000A [3 Months, 1 Year, and 2 Years Post Implant]
Performance index is defined as the subject's effective orifice area (the cross sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time.
- Subject's Average Performance Index Measurements - 11000M [3 Months, 1 Year, and 2 Years Post Implant]
Performance index is defined as the subject's effective orifice area (the crosssectional area of the blood flow downstream of the mitral valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time.
- Subject's Average Cardiac Output Over Time - 11000A [3 Months, 1 Year, and 2 Years Post Implant]
The amount of blood the heart pumps through the circulatory system in a minute.
- Subject's Average Cardiac Output Over Time - 11000M [3 Months, 1 Year, and 2 Years Post Implant]
The amount of blood the heart pumps through the circulatory system in a minute.
- Subject's Average Cardiac Index Over Time- 11000A [3 Months, 1 Year, and 2 Years Post Implant]
Cardiac index is an assessment that divides the cardiac output from left ventricle in one minute by the person's body surface area (BSA), thus relating heart performance to the size of the individual.
- Subject's Average Cardiac Index Over Time - 11000M [3 Months, 1 Year, and 2 Years Post Implant]
Cardiac index is an assessment that divides the cardiac output from left ventricle in one minute by the person's body surface area(BSA), thus relating heart performance to the size of the individual.
- Subject's Amount of Total Valvular Regurgitation Over Time - 11000A [3 Months, 1 Year, and 2 Years Post Implant]
Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.
- Subject's Amount of Total Valvular Regurgitation Over Time - 11000M [3 Months, 1 Year, and 2 Years Post Implant]
Mitral valvular regurgitation occurs when the mitral valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Mitral valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.
- Subject's Amount of Paravalvular Leak Over Time - 11000A [3 Months, 1 Year, and 2 Years Post Implant]
Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
- Subject's Amount of Paravalvular Leak Over Time - 11000M [3 Months, 1 Year, and 2 Years Post Implant]
Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
- Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline [3 Months, 1 Year, and 2 Years Post Implant]
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
- Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey [Baseline and one year post-implant]
The Medical Outcomes Study Short-Form 12 (SF-12) contains two components - the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The SF-12 Physical Component Summary questionnaire scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status. The SF-12 Mental Component Summary scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status.
- Subject's Average White Blood Cell Count [Baseline, Discharge, 3 Months, 1 Year and 2 Year]
Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection.
- Subject's Average Red Blood Cells Count [Baseline, Discharge, 3 Months, 1 Year and 2 Year]
Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen.
- Subject's Average Hematocrit Percentage [Baseline, Discharge, 3 Months, 1 Year and 2 Year]
Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the plasma (liquid portion of the blood).
- Subject's Average Hemoglobin Count [Baseline, Discharge, 3 Months, 1 Year and 2 Year]
Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.
- Subject's Average Platelet Count [Baseline, Discharge, 3 Months, 1 Year, and 2 Years]
Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.
- Subject's Average Plasma Free Hemoglobin [Baseline, Discharge, 3 Months, 1 Year and 2 Year]
Laboratory Analysis of Plasma Free Hemoglobin on blood drawn from subjects. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood).
- Subject's Average International Normalized Ratio [Baseline, Discharge, 3 Months, 1 Year and 2 Year]
Laboratory Analysis of International Normalized Ratio (INR) on blood drawn from subjects. The INR is a calculation based on results of a prothrombin time (PT). The PT is a blood test that measures the time it takes for the plasma (liquid portion of the blood) to clot. INR results will vary according to a person's age, the medicines they take, and any health problems they may have. In general, the higher the INR number, the longer it takes for the blood to clot. In healthy people an INR of 1.1 or below is considered normal. An INR range of 2.0 to 3.0 is generally an effective therapeutic range for people taking blood thinner medication.
- Subject's Average Partial Thromboplastin Time [Baseline, Discharge, 3 Months, 1 Year and 2 Year]
Laboratory Analysis of partial thromboplastin time (PTT) on blood drawn from subjects. PTT is a blood test that looks at how long it takes for the blood to clot.
- Subject's Average Prothrombin Time [Baseline, Discharge, 3 Months, 1 Year, and 2 Years]
Laboratory Analysis of Prothrombin Time (PT) on blood drawn from subjects. The PT is a blood test that measures the time it takes for the plasma (liquid portion of the blood) to clot.
- Subjects Average Serum Glycerol Levels [Pre-Implant (post-heparinization) and Post-Implant (between 60 and 120 minutes after heart was restarted)]
Laboratory analysis of serum glycerol in blood drawn from subjects. This blood test measures the amount of glycerol (a naturally occurring carbohydrate, that can be used as a fuel source by the body) in the serum (liquid portion of the blood).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Eligibility Criteria:
Inclusion Criteria:
-
Is 18 years or older
-
Provides written informed consent prior to trial procedures
-
Agrees to attend all follow-up assessments for up to 5 years and is willing to comply with specified follow-up evaluations at clinical investigational sites that are participating in the COMMENCE trial and/or obtain the protocol-specified diagnostic tests at centers that are under the same IRB or the same healthcare system
-
Diagnosed with aortic or mitral valve disease requiring valve replacement based on pre- operative evaluation
-
Scheduled to undergo planned aortic or mitral valve replacement with or without concomitant bypass surgery
-
Scheduled to undergo planned aortic valve replacement with or without resection and replacement of the ascending aorta from the sinotubular junction and without the need for circulatory arrest for hemi arch or arch replacement
Exclusion criteria:
A subject meeting any of the following criteria shall be excluded:
-
Requires emergency surgery
-
Requires planned multiple valve replacement/ repair (with the exception of mitral valve replacement with tricuspid valve repair)
-
Has prior valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ
-
Requires a surgical procedure outside of the cardiac area (e.g. vascular bypass)
-
Requires surgical replacement of the aortic root
-
Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months to the scheduled aortic or mitral valve replacement surgery
-
Has renal insufficiency as determined by creatinine (S-Cr) level ≥ 2.5 mg/dL or end -stage renal disease requiring chronic dialysis at screening visit
-
Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months (180 days) prior to planned valve surgery
-
Has acute myocardial infarction (MI) within 30 days prior to planned valve surgery
-
Has presence of non-cardiac disease limiting life expectancy to less than 12 months
-
Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM)
-
Diagnosed with abnormal calcium metabolism and hyperparathyroidism
-
Exhibits left ventricular ejection fraction ≤ 20% as validated by diagnostic procedure prior to planned valve surgery
-
Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
-
Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery
-
Documented leukopenia (WBC < 3.5x 10³/μL), acute anemia (Hgb < 10.0 gm/dL or 6 mmol/L) or thrombocytopenia (platelet count < 50x 10³/μL) accompanied by history of bleeding diathesis and coagulopathy
-
Has prior organ transplant or is currently an organ transplant candidate
-
Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial
-
Was previously implanted with trial device (Model 11000A or Model 11000M)
-
Pregnant (female subject of childbearing potential only), lactating or planning to become pregnant during the duration of participation in trial
-
Currently incarcerated or unable to give voluntary informed consent
-
Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant
-
Requires concomitant left ventricular assist device (LVAD) placement
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cardiology, P.C. | Birmingham | Alabama | United States | 35211 |
| 2 | University of Southern California | Los Angeles | California | United States | 90033 |
| 3 | Sutter Institute for Medical Research | Sacramento | California | United States | 95919 |
| 4 | Board of Trustees of the Leland Stanford Junior University | Stanford | California | United States | 94305 |
| 5 | Yale-New Haven | New Haven | Connecticut | United States | 06519 |
| 6 | Shands at the University of Florida | Gainesville | Florida | United States | 32610 |
| 7 | Florida Hospital | Orlando | Florida | United States | 32803 |
| 8 | Emory University Hospital Midtown | Atlanta | Georgia | United States | 30308 |
| 9 | St. Vincent Heart Center of Indiana | Indianapolis | Indiana | United States | 46290 |
| 10 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
| 11 | University of Maryland, Baltimore | Baltimore | Maryland | United States | 21201 |
| 12 | Spectrum Health Hospital | Grand Rapids | Michigan | United States | 49503 |
| 13 | North Mississippi Medical Center | Tupelo | Mississippi | United States | 38801 |
| 14 | Missouri Baptist Medical Center | Saint Louis | Missouri | United States | 36131 |
| 15 | Washington University/ Barnes Jewish Hospital | Saint Louis | Missouri | United States | 63110 |
| 16 | New York Weill Cornell Medical Center | New York | New York | United States | 10021 |
| 17 | Mount Sinai Morningside | New York | New York | United States | 10025 |
| 18 | Icahn School of Medicine at Mount Sinai | New York | New York | United States | 10029 |
| 19 | New York Presbyterian Hospital - Columbia University Medical Center | New York | New York | United States | 10032 |
| 20 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 21 | OhioHealth Research Institute | Columbus | Ohio | United States | 43124 |
| 22 | The Ohio State University Wexner Medical Center | Columbus | Ohio | United States | 43210 |
| 23 | Pinnacle Health Cardiovascular Institute | Harrisburg | Pennsylvania | United States | 17403 |
| 24 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19016 |
| 25 | St. Thomas Health | Nashville | Tennessee | United States | 37205 |
| 26 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 27 | Michael E. DeBakey VA Medical Center | Houston | Texas | United States | 77030 |
| 28 | The Heart Hospital of Baylor Plano | Plano | Texas | United States | 75093 |
| 29 | University of Utah | Salt Lake City | Utah | United States | 84132 |
| 30 | Institut Universitaire de Cardiologie et de Pneumologie de Québec | Quebec | Canada | G1V 4G5 | |
| 31 | Krakowski Szpital Specjalistyczny im. Jana Pawla II | Krakow | Poland | 31-202 | |
| 32 | The Cardinal Stefan Wyszynski Institute of Cardiology | Warsaw | Poland | 04-628 |
Sponsors and Collaborators
- Edwards Lifesciences
Investigators
- Principal Investigator: John Puskas, MD, Icahn School of Medicine at Mount Sinai
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01757665
Other Study ID Numbers:
- 2012-02
First Posted:
Dec 31, 2012
Last Update Posted:
Jan 26, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Edwards Lifesciences
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A | Edwards Pericardial Mitral Bioprosthesis, Model 11000M |
|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Period Title: Overall Study | ||
| STARTED | 694 | 83 |
| Implanted With Device | 689 | 82 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 694 | 83 |
Baseline Characteristics
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A | Edwards Pericardial Mitral Bioprosthesis, Model 11000M | Total |
|---|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | Total of all reporting groups |
| Overall Participants | 694 | 83 | 777 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
67
(11.6)
|
68.9
(9.3)
|
67.2
(11.4)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
196
28.2%
|
49
59%
|
245
31.5%
|
| Male |
498
71.8%
|
34
41%
|
532
68.5%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
2
0.3%
|
0
0%
|
2
0.3%
|
| Asian |
6
0.9%
|
2
2.4%
|
8
1%
|
| Native Hawaiian or Other Pacific Islander |
2
0.3%
|
0
0%
|
2
0.3%
|
| Black or African American |
23
3.3%
|
2
2.4%
|
25
3.2%
|
| White |
622
89.6%
|
73
88%
|
695
89.4%
|
| More than one race |
2
0.3%
|
0
0%
|
2
0.3%
|
| Unknown or Not Reported |
37
5.3%
|
6
7.2%
|
43
5.5%
|
Outcome Measures
| Title | Subjects With Structural Valve Deterioration |
|---|---|
| Description | The rate of implanted subjects that experience structural valve deterioration (SVD) of the trial valve by the time of the post operative day (POD) 390 follow-up visit. Structural valve deterioration includes dysfunction or deterioration intrinsic to the valve. Examples of SVD includes complications such as wear, fracture, calcification, leaflet tear. |
| Time Frame | 1 Year Post Implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available. The SVD result combines the aortic and mitral implanted subjects. The study was powered for the combined cohort for this endpoint as there would be too few mitral subjects to report the arms separately. |
| Arm/Group Title | Edwards Pericardial Bioprosthesis, Models 11000A & 11000M |
|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 716 |
| Count of Participants [Participants] |
1
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Edwards Pericardial Bioprosthesis, Models 11000A & 11000M |
|---|---|---|
| Comments | The null hypothesis is that the rate of structural valve deterioration at one year is greater than 1%. The alternative hypothesis is that this rate is less than 1%. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | percent of patients |
| Estimated Value | 0.1 | |
| Confidence Interval |
(1-Sided) 95% to 0.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Upper 95% CI was calculated by the method of Clopper and Pearson, using the Beta distribution with parameters x + 1 and n - x where x is the number of SVD events by POD 390 and n is the number of subjects followed at the 1 year assessment. | |
| Title | Percentage of Subjects With Early Adverse Events |
|---|---|
| Description | Number of subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100 |
| Time Frame | Events occuring within 30 days of procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A | Edwards Pericardial Mitral Bioprosthesis, Model 11000M |
|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 689 | 82 |
| All Cause Mortality |
1.2
|
1.2
|
| Trial Valve Related Mortality |
0.4
|
1.2
|
| Thromboembolism |
2.2
|
2.4
|
| Valve Thrombosis |
0.0
|
0.0
|
| All Bleeding |
0.9
|
1.2
|
| Major Bleeding |
0.7
|
1.2
|
| Endocarditis |
0.0
|
0.0
|
| Hemolysis |
0.0
|
0.0
|
| All Paravalvular Leak (OPC) |
0.3
|
0.0
|
| Major Paravalvular Leak (OPC) |
0.1
|
0.0
|
| Non-structural Valve Dysfunction |
0.0
|
0.0
|
| Reoperation |
0.1
|
0.0
|
| Explant |
0.0
|
0.0
|
| Title | Percentage of Late Adverse Events Divided by Late Patient Years |
|---|---|
| Description | Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event). |
| Time Frame | Events occurring >= 31 days and up through 3 years post-implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A | Edwards Pericardial Mitral Bioprosthesis, Model 11000M |
|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 689 | 82 |
| All Cause Mortality |
2.2
|
6.1
|
| Trial Valve Related Mortality |
0.7
|
0.9
|
| Thromboembolism |
2.1
|
1.7
|
| Valve Thrombosis |
0.0
|
0.0
|
| All Bleeding |
2.6
|
8.7
|
| Major Bleeding |
1.4
|
5.2
|
| Endocarditis |
0.6
|
0.9
|
| Hemolysis |
0.0
|
0.0
|
| All Paravalvular Leak (OPC) |
0.2
|
0.0
|
| Major Paravalvular Leak (OPC) |
0.1
|
0.0
|
| Non-structural Valve Dysfunction |
0.0
|
0.9
|
| Reoperation |
0.2
|
2.6
|
| Explant |
0.2
|
1.7
|
| Title | Subject's Average Mean Gradient Measurements - 11000A |
|---|---|
| Description | Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve. |
| Time Frame | 3 Months, 1 Year, and 2 Year Post Implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 19mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 21mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. |
| Measure Participants | 22 | 131 | 214 | 202 | 100 | 20 | 689 |
| 3 Months |
13.8
(6.1)
|
10.7
(4.2)
|
9.4
(3.8)
|
8.7
(3.4)
|
6.8
(2.6)
|
4.7
(1.3)
|
9.1
(4.0)
|
| 1 Year |
17.6
(7.8)
|
12.6
(4.7)
|
10.1
(3.8)
|
9.6
(5.2)
|
8.2
(3.5)
|
10.4
(4.9)
|
|
| 2 Year |
16.1
(6.4)
|
11.2
(4.0)
|
9.9
(4.4)
|
9.2
(3.4)
|
8.3
(3.5)
|
10.1
(4.3)
|
| Title | Subject's Average Mean Gradient Measurements - 11000M |
|---|---|
| Description | Mean gradient is the average flow of blood through the mitral valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve. |
| Time Frame | 3 Months, 1 Year, and 2 Years Post Implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 33mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 6 | 29 | 25 | 16 | 6 | 82 |
| 3 Months |
5.6
(0.7)
|
4.1
(1.7)
|
4.0
(1.5)
|
3.4
(1.3)
|
3.3
(1.4)
|
4.0
(1.6)
|
| 1 Year |
4.9
(1.2)
|
4.1
(1.4)
|
4.1
(1.5)
|
3.9
(2.0)
|
3.3
(1.4)
|
4.0
(1.5)
|
| 2 Year |
3.9
(1.8)
|
3.8
(1.0)
|
3.5
(0.8)
|
3.4
(2.5)
|
3.8
(1.5)
|
| Title | Subject's Average Peak Gradients Measurements Over Time - 11000A |
|---|---|
| Description | Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. |
| Time Frame | 3 Months, 1 Year, and 2 Years Post Implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 19mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 21mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. |
| Measure Participants | 22 | 131 | 214 | 202 | 100 | 20 | 689 |
| 3 Month |
27.5
(12.3)
|
21.7
(8.2)
|
18.8
(6.9)
|
17.5
(6.3)
|
13.8
(4.9)
|
10.1
(3.0)
|
18.4
(7.6)
|
| 1 Year |
35.0
(16.3)
|
25.2
(8.9)
|
20.1
(7.5)
|
19.2
(8.9)
|
16.7
(6.9)
|
20.9
(9.3)
|
|
| 2 Year |
31.7
(12.0)
|
22.0
(7.5)
|
19.8
(8.5)
|
18.2
(6.0)
|
16.4
(6.6)
|
20.1
(8.2)
|
| Title | Subject's Average Peak Gradients Measurements Over Time - 11000M |
|---|---|
| Description | Peak gradient is the maximum value measured of flow of blood through the mitral valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. |
| Time Frame | 3 Months, 1 Year, and 2 Years Post Implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 33mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 6 | 29 | 25 | 16 | 6 | 82 |
| 3 Months |
12.0
(1.4)
|
9.8
(4.0)
|
10.2
(4.2)
|
9.0
(2.8)
|
17.4
(22.1)
|
10.5
(7.1)
|
| 1 Year |
10.6
(3.0)
|
9.9
(3.2)
|
10.4
(3.7)
|
10.2
(5.5)
|
9.0
(4.1)
|
10.1
(3.8)
|
| 2 Year |
9.5
(4.7)
|
10.5
(3.4)
|
6.6
(1.2)
|
8.3
(3.4)
|
9.4
(4.0)
|
| Title | Subject's Average Effective Orifice Area Measurements - 11000A |
|---|---|
| Description | Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. |
| Time Frame | 3 Months, 1 Year, and 2 Years Post Implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 19mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 21mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. |
| Measure Participants | 22 | 131 | 214 | 202 | 100 | 20 | 689 |
| 3 Months |
1.4
(0.4)
|
1.5
(0.4)
|
1.7
(0.4)
|
1.8
(0.5)
|
2.3
(0.7)
|
2.5
(0.8)
|
1.8
(0.6)
|
| 1 Year |
1.1
(0.2)
|
1.3
(0.3)
|
1.6
(0.4)
|
1.8
(0.5)
|
2.2
(0.6)
|
1.7
(0.5)
|
|
| 2 Year |
1.0
(0.4)
|
1.3
(0.3)
|
1.6
(0.4)
|
1.9
(0.5)
|
1.8
(0.5)
|
1.6
(0.5)
|
| Title | Subject's Average Effective Orifice Area Measurements - 11000M |
|---|---|
| Description | Effective orifice area represents the cross-sectional area of the blood flow downstream of the mitral valve. Effective orifice area is evaluated by echocardiography over time. |
| Time Frame | 3 Months, 1 Year, and 2 Years Post Implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 33mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 6 | 29 | 25 | 16 | 6 | 82 |
| 3 Months |
1.2
(0.3)
|
1.4
(0.4)
|
1.6
(0.6)
|
1.6
(0.4)
|
1.8
(0.4)
|
1.5
(0.5)
|
| 1 Year |
1.1
(0.4)
|
1.2
(0.3)
|
1.5
(0.6)
|
1.4
(0.5)
|
1.5
(0.7)
|
1.4
(0.5)
|
| 2 Year |
1.3
(0.5)
|
1.4
(0.4)
|
1.6
(0.0)
|
1.2
(0.3)
|
1.4
(0.4)
|
| Title | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A |
|---|---|
| Description | Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. |
| Time Frame | 3 Months, 1 Year, and 2 Years Post Implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 19mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 21mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. |
| Measure Participants | 22 | 131 | 214 | 202 | 100 | 20 | 689 |
| 3 Months |
0.8
(0.3)
|
0.8
(0.3)
|
0.9
(0.3)
|
0.9
(0.3)
|
1.1
(0.3)
|
1.1
(0.3)
|
0.9
(0.3)
|
| 1 Year |
0.6
(0.1)
|
0.7
(0.2)
|
0.8
(0.2)
|
0.8
(0.2)
|
1.0
(0.3)
|
0.8
(0.3)
|
|
| 2 Year |
0.6
(0.3)
|
0.7
(0.2)
|
0.8
(0.2)
|
0.9
(0.2)
|
0.8
(0.2)
|
0.8
(0.2)
|
| Title | Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M |
|---|---|
| Description | Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. |
| Time Frame | 3 Months, 1 Year, and 2 Years Post Implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 33mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 6 | 29 | 25 | 16 | 6 | 82 |
| 3 Months |
0.7
(0.2)
|
0.8
(0.3)
|
0.8
(0.3)
|
0.8
(0.2)
|
0.9
(0.2)
|
0.8
(0.3)
|
| 1 Year |
0.6
(0.2)
|
0.7
(0.2)
|
0.8
(0.3)
|
0.7
(0.2)
|
0.7
(0.3)
|
0.7
(0.2)
|
| 2 Year |
0.8
(0.3)
|
0.7
(0.2)
|
0.9
(0.2)
|
0.6
(0.1)
|
0.7
(0.3)
|
| Title | Subject's Average Performance Index Measurements - 11000A |
|---|---|
| Description | Performance index is defined as the subject's effective orifice area (the cross sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time. |
| Time Frame | 3 Months, 1 Year, and 2 Years Post Implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 19mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 21mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. |
| Measure Participants | 22 | 131 | 214 | 202 | 100 | 20 | 689 |
| 3 Months |
1.1
(0.3)
|
0.9
(0.2)
|
0.9
(0.2)
|
0.9
(0.2)
|
0.9
(0.3)
|
0.8
(0.3)
|
0.9
(0.2)
|
| 1 Year |
0.9
(0.2)
|
0.8
(0.2)
|
0.8
(0.2)
|
0.8
(0.2)
|
0.9
(0.2)
|
0.8
(0.2)
|
|
| 2 Year |
0.8
(0.3)
|
0.8
(0.2)
|
0.8
(0.2)
|
0.9
(0.2)
|
0.7
(0.2)
|
0.8
(0.2)
|
| Title | Subject's Average Performance Index Measurements - 11000M |
|---|---|
| Description | Performance index is defined as the subject's effective orifice area (the crosssectional area of the blood flow downstream of the mitral valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time. |
| Time Frame | 3 Months, 1 Year, and 2 Years Post Implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 33mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 6 | 29 | 25 | 16 | 6 | 82 |
| 3 Months |
0.6
(0.2)
|
0.6
(0.2)
|
0.6
(0.2)
|
0.5
(0.1)
|
0.6
(0.1)
|
0.6
(0.2)
|
| 1 Year |
0.6
(0.2)
|
0.6
(0.2)
|
0.6
(0.2)
|
0.5
(0.2)
|
0.5
(0.2)
|
0.5
(0.2)
|
| 2 Year |
0.6
(0.2)
|
0.6
(0.2)
|
0.6
(0.0)
|
0.4
(0.1)
|
0.6
(0.2)
|
| Title | Subject's Average Cardiac Output Over Time - 11000A |
|---|---|
| Description | The amount of blood the heart pumps through the circulatory system in a minute. |
| Time Frame | 3 Months, 1 Year, and 2 Years Post Implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 19mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 21mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. |
| Measure Participants | 22 | 131 | 214 | 202 | 100 | 20 | 689 |
| 3 Months |
5.1
(1.3)
|
4.5
(1.2)
|
4.7
(1.4)
|
4.8
(1.2)
|
5.2
(1.8)
|
4.4
(1.2)
|
4.8
(1.4)
|
| 1 Year |
4.5
(0.9)
|
4.7
(1.8)
|
4.4
(1.2)
|
4.8
(1.7)
|
5.4
(1.6)
|
4.7
(1.6)
|
|
| 2 Year |
3.7
(1.1)
|
4.3
(1.1)
|
4.4
(1.2)
|
4.9
(1.7)
|
4.4
(1.4)
|
4.5
(1.4)
|
| Title | Subject's Average Cardiac Output Over Time - 11000M |
|---|---|
| Description | The amount of blood the heart pumps through the circulatory system in a minute. |
| Time Frame | 3 Months, 1 Year, and 2 Years Post Implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 33mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 6 | 29 | 25 | 16 | 6 | 82 |
| 3 Months |
4.0
(1.2)
|
3.6
(0.9)
|
4.3
(1.4)
|
3.9
(0.8)
|
4.6
(1.0)
|
4.0
(1.1)
|
| 1 Year |
3.7
(1.0)
|
3.3
(1.1)
|
4.4
(1.9)
|
3.8
(1.1)
|
3.8
(0.8)
|
3.8
(1.4)
|
| 2 Year |
3.3
(1.1)
|
4.1
(1.3)
|
3.6
(0.3)
|
3.3
(0.6)
|
3.6
(1.1)
|
| Title | Subject's Average Cardiac Index Over Time- 11000A |
|---|---|
| Description | Cardiac index is an assessment that divides the cardiac output from left ventricle in one minute by the person's body surface area (BSA), thus relating heart performance to the size of the individual. |
| Time Frame | 3 Months, 1 Year, and 2 Years Post Implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 19mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 21mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. |
| Measure Participants | 22 | 131 | 214 | 202 | 100 | 20 | 689 |
| 3 Months |
3.0
(0.8)
|
2.4
(0.7)
|
2.4
(0.8)
|
2.3
(0.6)
|
2.4
(0.9)
|
2.0
(0.4)
|
2.4
(0.7)
|
| 1 Year |
2.6
(0.5)
|
2.5
(1.0)
|
2.2
(0.6)
|
2.2
(0.8)
|
2.4
(0.7)
|
2.3
(0.8)
|
|
| 2 Year |
2.2
(0.8)
|
2.3
(0.6)
|
2.2
(0.7)
|
2.3
(0.7)
|
2.0
(0.6)
|
2.2
(0.7)
|
| Title | Subject's Average Cardiac Index Over Time - 11000M |
|---|---|
| Description | Cardiac index is an assessment that divides the cardiac output from left ventricle in one minute by the person's body surface area(BSA), thus relating heart performance to the size of the individual. |
| Time Frame | 3 Months, 1 Year, and 2 Years Post Implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 33mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 6 | 29 | 25 | 16 | 6 | 82 |
| 3 Months |
2.2
(0.7)
|
2.1
(0.6)
|
2.2
(0.6)
|
1.9
(0.4)
|
2.1
(0.8)
|
2.1
(0.6)
|
| 1 Year |
2.0
(0.5)
|
1.9
(0.5)
|
2.2
(0.9)
|
1.9
(0.5)
|
1.8
(0.4)
|
2.0
(0.7)
|
| 2 Year |
1.9
(0.7)
|
2.1
(0.5)
|
1.9
(0.3)
|
1.6
(0.3)
|
1.9
(0.6)
|
| Title | Subject's Amount of Total Valvular Regurgitation Over Time - 11000A |
|---|---|
| Description | Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. |
| Time Frame | 3 Months, 1 Year, and 2 Years Post Implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 19mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 21mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. |
| Measure Participants | 22 | 131 | 214 | 202 | 100 | 20 | 689 |
| 0 None |
17
2.4%
|
106
127.7%
|
166
21.4%
|
162
NaN
|
69
NaN
|
11
NaN
|
531
NaN
|
| +1 Trivial/Trace |
3
0.4%
|
11
13.3%
|
25
3.2%
|
20
NaN
|
20
NaN
|
1
NaN
|
80
NaN
|
| +2 Mild |
1
0.1%
|
1
1.2%
|
3
0.4%
|
4
NaN
|
1
NaN
|
0
NaN
|
10
NaN
|
| +3 Moderate |
0
0%
|
0
0%
|
1
0.1%
|
0
NaN
|
0
NaN
|
0
NaN
|
1
NaN
|
| +4 Severe |
0
0%
|
0
0%
|
1
0.1%
|
0
NaN
|
0
NaN
|
0
NaN
|
1
NaN
|
| 0 None |
11
1.6%
|
88
106%
|
125
16.1%
|
112
NaN
|
49
NaN
|
385
NaN
|
|
| +1 Trivial/Trace |
3
0.4%
|
6
7.2%
|
26
3.3%
|
12
NaN
|
17
NaN
|
64
NaN
|
|
| +2 Mild |
2
0.3%
|
2
2.4%
|
8
1%
|
7
NaN
|
2
NaN
|
21
NaN
|
|
| +3 Moderate |
0
0%
|
1
1.2%
|
0
0%
|
0
NaN
|
0
NaN
|
1
NaN
|
|
| +4 Severe |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
|
| 0 None |
4
0.6%
|
32
38.6%
|
51
6.6%
|
38
NaN
|
11
NaN
|
136
NaN
|
|
| +1 Trivial/Trace |
2
0.3%
|
5
6%
|
11
1.4%
|
9
NaN
|
5
NaN
|
32
NaN
|
|
| +2 Mild |
2
0.3%
|
5
6%
|
3
0.4%
|
2
NaN
|
2
NaN
|
14
NaN
|
|
| +3 Moderate |
0
0%
|
0
0%
|
1
0.1%
|
0
NaN
|
0
NaN
|
1
NaN
|
|
| +4 Severe |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Title | Subject's Amount of Total Valvular Regurgitation Over Time - 11000M |
|---|---|
| Description | Mitral valvular regurgitation occurs when the mitral valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Mitral valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. |
| Time Frame | 3 Months, 1 Year, and 2 Years Post Implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 33mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 6 | 29 | 25 | 16 | 6 | 82 |
| 0 None |
4
0.6%
|
15
18.1%
|
18
2.3%
|
10
NaN
|
4
NaN
|
51
NaN
|
| +1 Trivial/Trace |
1
0.1%
|
7
8.4%
|
5
0.6%
|
3
NaN
|
2
NaN
|
18
NaN
|
| +2 Mild |
0
0%
|
3
3.6%
|
0
0%
|
2
NaN
|
0
NaN
|
5
NaN
|
| +3 Moderate |
0
0%
|
1
1.2%
|
0
0%
|
0
NaN
|
0
NaN
|
1
NaN
|
| +4 Severe |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| 0 None |
3
0.4%
|
15
18.1%
|
13
1.7%
|
8
NaN
|
3
NaN
|
42
NaN
|
| +1 Trivial/Trace |
1
0.1%
|
5
6%
|
7
0.9%
|
4
NaN
|
2
NaN
|
19
NaN
|
| +2 Mild |
0
0%
|
4
4.8%
|
0
0%
|
0
NaN
|
1
NaN
|
5
NaN
|
| +3 Moderate |
0
0%
|
1
1.2%
|
1
0.1%
|
0
NaN
|
0
NaN
|
2
NaN
|
| +4 Severe |
0
0%
|
0
0%
|
0
0%
|
1
NaN
|
0
NaN
|
1
NaN
|
| 0 None |
6
0.9%
|
6
7.2%
|
1
0.1%
|
0
NaN
|
13
NaN
|
|
| +1 Trivial/Trace |
2
0.3%
|
1
1.2%
|
1
0.1%
|
2
NaN
|
6
NaN
|
|
| +2 Mild |
4
0.6%
|
0
0%
|
0
0%
|
0
NaN
|
4
NaN
|
|
| +3 Moderate |
1
0.1%
|
0
0%
|
0
0%
|
0
NaN
|
1
NaN
|
|
| +4 Severe |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
| Title | Subject's Amount of Paravalvular Leak Over Time - 11000A |
|---|---|
| Description | Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome. |
| Time Frame | 3 Months, 1 Year, and 2 Years Post Implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 19mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 21mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 23mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 25mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm | Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. |
| Measure Participants | 22 | 131 | 214 | 202 | 100 | 20 | 689 |
| 0 None |
20
2.9%
|
118
142.2%
|
191
24.6%
|
182
NaN
|
87
NaN
|
12
NaN
|
610
NaN
|
| +1 Trivial/Trace |
1
0.1%
|
0
0%
|
3
0.4%
|
1
NaN
|
2
NaN
|
0
NaN
|
7
NaN
|
| +2 Mild |
0
0%
|
0
0%
|
0
0%
|
2
NaN
|
1
NaN
|
0
NaN
|
3
NaN
|
| +3 Moderate |
0
0%
|
0
0%
|
1
0.1%
|
0
NaN
|
0
NaN
|
0
NaN
|
1
NaN
|
| +4 Severe |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| 0 None |
12
1.7%
|
92
110.8%
|
152
19.6%
|
127
NaN
|
67
NaN
|
450
NaN
|
|
| +1 Trivial/Trace |
2
0.3%
|
1
1.2%
|
3
0.4%
|
2
NaN
|
0
NaN
|
8
NaN
|
|
| +2 Mild |
1
0.1%
|
3
3.6%
|
3
0.4%
|
1
NaN
|
2
NaN
|
10
NaN
|
|
| +3 Moderate |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
|
| +4 Severe |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
|
| 0 None |
6
0.9%
|
37
44.6%
|
61
7.9%
|
46
NaN
|
16
NaN
|
166
NaN
|
|
| +1 Trivial/Trace |
0
0%
|
1
1.2%
|
2
0.3%
|
1
NaN
|
2
NaN
|
6
NaN
|
|
| +2 Mild |
2
0.3%
|
4
4.8%
|
2
0.3%
|
1
NaN
|
0
NaN
|
9
NaN
|
|
| +3 Moderate |
0
0%
|
0
0%
|
1
0.1%
|
0
NaN
|
0
NaN
|
1
NaN
|
|
| +4 Severe |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Title | Subject's Amount of Paravalvular Leak Over Time - 11000M |
|---|---|
| Description | Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome. |
| Time Frame | 3 Months, 1 Year, and 2 Years Post Implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 33mm | Edwards Pericardial Mitral Bioprosthesis, Model 11000M - Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 6 | 29 | 25 | 16 | 6 | 82 |
| 0 None |
5
0.7%
|
26
31.3%
|
23
3%
|
15
NaN
|
6
NaN
|
75
NaN
|
| +1 Trivial/Trace |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| +2 Mild |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| +3 Moderate |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| +4 Severe |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| 0 None |
4
0.6%
|
25
30.1%
|
21
2.7%
|
11
NaN
|
6
NaN
|
67
NaN
|
| +1 Trivial/Trace |
0
0%
|
0
0%
|
0
0%
|
2
NaN
|
0
NaN
|
2
NaN
|
| +2 Mild |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| +3 Moderate |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| +4 Severe |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| 0 None |
13
1.9%
|
7
8.4%
|
2
0.3%
|
2
NaN
|
24
NaN
|
|
| +1 Trivial/Trace |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
|
| +2 Mild |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
|
| +3 Moderate |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
|
| +4 Severe |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
| Title | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline |
|---|---|
| Description | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. |
| Time Frame | 3 Months, 1 Year, and 2 Years Post Implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A | Edwards Pericardial Mitral Bioprosthesis, Model 11000M |
|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 689 | 82 |
| Improved |
431
62.1%
|
66
79.5%
|
| Same |
200
28.8%
|
7
8.4%
|
| Worsened |
14
2%
|
2
2.4%
|
| Improved |
331
47.7%
|
66
79.5%
|
| Same |
161
23.2%
|
7
8.4%
|
| Worsened |
17
2.4%
|
0
0%
|
| Improved |
157
22.6%
|
26
31.3%
|
| Same |
75
10.8%
|
3
3.6%
|
| Worsened |
8
1.2%
|
0
0%
|
| Title | Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey |
|---|---|
| Description | The Medical Outcomes Study Short-Form 12 (SF-12) contains two components - the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The SF-12 Physical Component Summary questionnaire scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status. The SF-12 Mental Component Summary scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status. |
| Time Frame | Baseline and one year post-implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A | Edwards Pericardial Mitral Bioprosthesis, Model 11000M |
|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 689 | 82 |
| Physical Health-Baseline |
42.9
(9.7)
|
40.1
(8.9)
|
| Physical Health-1 Year |
49.1
(9.2)
|
48.8
(7.0)
|
| Mental Health-Baseline |
50.9
(9.5)
|
49.2
(11.5)
|
| Mental Health-1 Year |
53.8
(8.5)
|
52.3
(9.3)
|
| Title | Subject's Average White Blood Cell Count |
|---|---|
| Description | Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection. |
| Time Frame | Baseline, Discharge, 3 Months, 1 Year and 2 Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A | Edwards Pericardial Mitral Bioprosthesis, Model 11000M |
|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 689 | 82 |
| Baseline |
7.2
(1.9)
|
7.4
(2.6)
|
| Discharge |
9.1
(2.8)
|
10.4
(5.3)
|
| 3 Months |
7.1
(1.7)
|
7.1
(2.0)
|
| 1 Year |
7.3
(1.9)
|
7.1
(2.3)
|
| 2 Year |
7.3
(1.8)
|
7.4
(1.8)
|
| Title | Subject's Average Red Blood Cells Count |
|---|---|
| Description | Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen. |
| Time Frame | Baseline, Discharge, 3 Months, 1 Year and 2 Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A | Edwards Pericardial Mitral Bioprosthesis, Model 11000M |
|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 689 | 82 |
| Baseline |
4.5
(0.5)
|
4.4
(0.6)
|
| Discharge |
3.3
(0.5)
|
3.3
(0.4)
|
| 3 Months |
4.7
(0.5)
|
4.5
(0.7)
|
| 1 Year |
4.7
(0.5)
|
4.5
(0.6)
|
| 2 Year |
4.6
(0.5)
|
4.6
(0.5)
|
| Title | Subject's Average Hematocrit Percentage |
|---|---|
| Description | Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the plasma (liquid portion of the blood). |
| Time Frame | Baseline, Discharge, 3 Months, 1 Year and 2 Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A | Edwards Pericardial Mitral Bioprosthesis, Model 11000M |
|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 689 | 82 |
| Baseline |
41.0
(4.0)
|
40.3
(4.6)
|
| Discharge |
30.1
(4.1)
|
30.1
(3.9)
|
| 3 Months |
41.0
(4.2)
|
39.3
(5.3)
|
| 1 Year |
41.9
(4.1)
|
41.3
(4.8)
|
| 2 Year |
42.0
(3.9)
|
42.4
(4.3)
|
| Title | Subject's Average Hemoglobin Count |
|---|---|
| Description | Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. |
| Time Frame | Baseline, Discharge, 3 Months, 1 Year and 2 Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A | Edwards Pericardial Mitral Bioprosthesis, Model 11000M |
|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 689 | 82 |
| Baseline |
13.8
(1.5)
|
13.3
(1.6)
|
| Discharge |
10.0
(1.4)
|
9.9
(1.2)
|
| 3 Months |
13.5
(1.6)
|
12.7
(1.9)
|
| 1 Year |
14.0
(1.7)
|
13.6
(1.6)
|
| 2 Year |
14.0
(1.5)
|
14.0
(1.3)
|
| Title | Subject's Average Platelet Count |
|---|---|
| Description | Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting. |
| Time Frame | Baseline, Discharge, 3 Months, 1 Year, and 2 Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A | Edwards Pericardial Mitral Bioprosthesis, Model 11000M |
|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 689 | 82 |
| Baseline |
208.6
(59.0)
|
203.6
(52.1)
|
| Discharge |
217.7
(90.1)
|
196.0
(75.3)
|
| 3 Months |
215.3
(62.6)
|
221.0
(71.8)
|
| 1 Year |
207.7
(65.8)
|
207.8
(51.7)
|
| 2 Year |
200.6
(54.5)
|
204.0
(54.1)
|
| Title | Subject's Average Plasma Free Hemoglobin |
|---|---|
| Description | Laboratory Analysis of Plasma Free Hemoglobin on blood drawn from subjects. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood). |
| Time Frame | Baseline, Discharge, 3 Months, 1 Year and 2 Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A | Edwards Pericardial Mitral Bioprosthesis, Model 11000M |
|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 689 | 82 |
| Baseline |
11.6
(18.4)
|
19.8
(32.5)
|
| Discharge |
7.3
(12.2)
|
7.2
(6.5)
|
| 3 Months |
12.4
(22.2)
|
10.6
(12.1)
|
| 1 Year |
13.8
(25.5)
|
8.6
(12.3)
|
| 2 Year |
17.3
(33.9)
|
20.5
(33.9)
|
| Title | Subject's Average International Normalized Ratio |
|---|---|
| Description | Laboratory Analysis of International Normalized Ratio (INR) on blood drawn from subjects. The INR is a calculation based on results of a prothrombin time (PT). The PT is a blood test that measures the time it takes for the plasma (liquid portion of the blood) to clot. INR results will vary according to a person's age, the medicines they take, and any health problems they may have. In general, the higher the INR number, the longer it takes for the blood to clot. In healthy people an INR of 1.1 or below is considered normal. An INR range of 2.0 to 3.0 is generally an effective therapeutic range for people taking blood thinner medication. |
| Time Frame | Baseline, Discharge, 3 Months, 1 Year and 2 Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A | Edwards Pericardial Mitral Bioprosthesis, Model 11000M |
|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 689 | 82 |
| Baseline |
1.1
(0.2)
|
1.4
(0.7)
|
| Discharge |
1.3
(0.4)
|
1.7
(0.6)
|
| 3 Months |
1.3
(0.7)
|
1.9
(0.8)
|
| 1 Year |
1.2
(0.5)
|
1.7
(0.8)
|
| 2 Year |
1.2
(0.6)
|
1.6
(0.8)
|
| Title | Subject's Average Partial Thromboplastin Time |
|---|---|
| Description | Laboratory Analysis of partial thromboplastin time (PTT) on blood drawn from subjects. PTT is a blood test that looks at how long it takes for the blood to clot. |
| Time Frame | Baseline, Discharge, 3 Months, 1 Year and 2 Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A | Edwards Pericardial Mitral Bioprosthesis, Model 11000M |
|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 689 | 82 |
| Baseline |
30.0
(6.0)
|
35.1
(14.4)
|
| Discharge |
32.1
(8.5)
|
37.2
(14.5)
|
| 3 Months |
31.2
(15.8)
|
36.0
(8.1)
|
| 1 Year |
29.4
(5.7)
|
35.3
(14.3)
|
| 2 Year |
31.4
(14.4)
|
33.7
(9.5)
|
| Title | Subject's Average Prothrombin Time |
|---|---|
| Description | Laboratory Analysis of Prothrombin Time (PT) on blood drawn from subjects. The PT is a blood test that measures the time it takes for the plasma (liquid portion of the blood) to clot. |
| Time Frame | Baseline, Discharge, 3 Months, 1 Year, and 2 Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available. |
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A | Edwards Pericardial Mitral Bioprosthesis, Model 11000M |
|---|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. |
| Measure Participants | 689 | 82 |
| Baseline |
12.7
(2.5)
|
16.2
(8.0)
|
| Discharge |
15.0
(5.0)
|
20.1
(7.3)
|
| 3 Months |
15.2
(7.4)
|
21.0
(8.4)
|
| 1 Year |
13.8
(5.7)
|
19.1
(8.8)
|
| 2 Year |
14.1
(6.4)
|
17.3
(7.9)
|
| Title | Subjects Average Serum Glycerol Levels |
|---|---|
| Description | Laboratory analysis of serum glycerol in blood drawn from subjects. This blood test measures the amount of glycerol (a naturally occurring carbohydrate, that can be used as a fuel source by the body) in the serum (liquid portion of the blood). |
| Time Frame | Pre-Implant (post-heparinization) and Post-Implant (between 60 and 120 minutes after heart was restarted) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects who received the Model 11000A device where data is available. |
| Arm/Group Title | Edwards Pericardial Bioprosthesis, Model 11000A |
|---|---|
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. |
| Measure Participants | 689 |
| Pre-Implant |
405.4
(270.2)
|
| Post-Implant |
245.6
(345.8)
|
Adverse Events
| Time Frame | Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device. | |||
| Arm/Group Title | Edwards Pericardial Aortic Bioprosthesis, Model 11000A | Edwards Pericardial Mitral Bioprosthesis, Model 11000M | ||
| Arm/Group Description | The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve. | The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve. | ||
All Cause Mortality |
||||
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A | Edwards Pericardial Mitral Bioprosthesis, Model 11000M | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 26/689 (3.8%) | 8/82 (9.8%) | ||
Serious Adverse Events |
||||
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A | Edwards Pericardial Mitral Bioprosthesis, Model 11000M | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 317/689 (46%) | 58/82 (70.7%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia - Bleeding related - Major | 12/689 (1.7%) | 12 | 2/82 (2.4%) | 2 |
| Anemia - Bleeding related - Minor | 11/689 (1.6%) | 11 | 1/82 (1.2%) | 1 |
| Anemia - Non-bleeding related | 6/689 (0.9%) | 6 | 3/82 (3.7%) | 3 |
| Bleeding - Cardiovascular - Major | 21/689 (3%) | 21 | 3/82 (3.7%) | 3 |
| Bleeding - Cardiovascular - Minor | 5/689 (0.7%) | 5 | 1/82 (1.2%) | 1 |
| Bleeding - Gastrointestinal lower - Major | 3/689 (0.4%) | 3 | 0/82 (0%) | 0 |
| Bleeding - Gastrointestinal lower - Minor | 1/689 (0.1%) | 1 | 0/82 (0%) | 0 |
| Bleeding - Gastrointestinal upper - Major | 4/689 (0.6%) | 5 | 2/82 (2.4%) | 2 |
| Bleeding - Genitourinary - Minor | 1/689 (0.1%) | 1 | 0/82 (0%) | 0 |
| Bleeding - Musculoskeletal/Dermatological - Major (e.g. ecchymosis) | 1/689 (0.1%) | 1 | 0/82 (0%) | 0 |
| Bleeding - Neurological - Minor (e.g. CVA) | 2/689 (0.3%) | 2 | 4/82 (4.9%) | 4 |
| Bleeding - Peripheral vascular - Minor (e.g. nosebleeds; hematomas) | 0/689 (0%) | 0 | 1/82 (1.2%) | 1 |
| Bleeding - Pulmonary/Respiratory - Major (e.g. hemothorax) | 2/689 (0.3%) | 2 | 0/82 (0%) | 0 |
| Blood sepsis | 9/689 (1.3%) | 10 | 3/82 (3.7%) | 4 |
| Blood/Lymphatic - Other | 6/689 (0.9%) | 6 | 0/82 (0%) | 0 |
| Thrombocytopenia - Heparin Induced (HIT) | 0/689 (0%) | 0 | 2/82 (2.4%) | 2 |
| Thrombocytopenia - Non-heparin induced | 2/689 (0.3%) | 2 | 1/82 (1.2%) | 1 |
| Cardiac disorders | ||||
| Angina, stable | 1/689 (0.1%) | 1 | 2/82 (2.4%) | 2 |
| Angina, unstable | 3/689 (0.4%) | 3 | 0/82 (0%) | 0 |
| Arrhythmia - Atrial flutter | 7/689 (1%) | 7 | 3/82 (3.7%) | 3 |
| Arrhythmia - AV block - 1st degree | 1/689 (0.1%) | 1 | 0/82 (0%) | 0 |
| Arrhythmia - AV block - 2nd degree | 4/689 (0.6%) | 4 | 0/82 (0%) | 0 |
| Arrhythmia - AV block - 3rd degree | 24/689 (3.5%) | 24 | 6/82 (7.3%) | 6 |
| Arrhythmia - Bradycardia | 4/689 (0.6%) | 4 | 1/82 (1.2%) | 1 |
| Arrhythmia - Bundle branch block - Left | 1/689 (0.1%) | 1 | 0/82 (0%) | 0 |
| Arrhythmia - Bundle branch block - Right | 2/689 (0.3%) | 2 | 0/82 (0%) | 0 |
| Arrhythmia - Other | 10/689 (1.5%) | 10 | 5/82 (6.1%) | 5 |
| Arrhythmia - Paroxysmal Atrial Fibrillation (PAF) | 39/689 (5.7%) | 41 | 8/82 (9.8%) | 9 |
| Arrhythmia - Permanent atrial fibrillation | 2/689 (0.3%) | 2 | 1/82 (1.2%) | 1 |
| Arrhythmia - Persistent atrial fibrillation | 14/689 (2%) | 14 | 6/82 (7.3%) | 6 |
| Arrhythmia - Supraventricular Tachycardia (SVT) | 3/689 (0.4%) | 3 | 1/82 (1.2%) | 1 |
| Arrhythmia - Tachy-bradycardia | 4/689 (0.6%) | 4 | 1/82 (1.2%) | 1 |
| Arrhythmia - Tachycardia - Ventricular | 2/689 (0.3%) | 2 | 0/82 (0%) | 0 |
| Arrhythmia - Ventricular fibrillation | 4/689 (0.6%) | 4 | 0/82 (0%) | 0 |
| Cardiac arrest | 6/689 (0.9%) | 6 | 3/82 (3.7%) | 3 |
| Cardiac decompensation | 1/689 (0.1%) | 1 | 1/82 (1.2%) | 1 |
| Cardiogenic shock | 6/689 (0.9%) | 6 | 1/82 (1.2%) | 1 |
| Cardiovascular - Other | 23/689 (3.3%) | 24 | 6/82 (7.3%) | 7 |
| Coronary artery ostial obstruction | 2/689 (0.3%) | 2 | 0/82 (0%) | 0 |
| Endocarditis | 7/689 (1%) | 7 | 2/82 (2.4%) | 2 |
| Heart failure - Acute | 7/689 (1%) | 7 | 5/82 (6.1%) | 5 |
| Heart Failure - Chronic (CHF) | 11/689 (1.6%) | 13 | 3/82 (3.7%) | 7 |
| Hypertension - Systemic | 1/689 (0.1%) | 1 | 0/82 (0%) | 0 |
| Hypotension | 8/689 (1.2%) | 8 | 4/82 (4.9%) | 4 |
| Myocardial infarction | 2/689 (0.3%) | 2 | 0/82 (0%) | 0 |
| Pericardial effusion - Major | 8/689 (1.2%) | 9 | 2/82 (2.4%) | 2 |
| Pericardial effusion - Minor | 6/689 (0.9%) | 6 | 0/82 (0%) | 0 |
| Pericardial tamponade | 10/689 (1.5%) | 10 | 1/82 (1.2%) | 1 |
| Pericarditis | 5/689 (0.7%) | 6 | 0/82 (0%) | 0 |
| Pleural effusion - Bilateral | 13/689 (1.9%) | 13 | 1/82 (1.2%) | 1 |
| Pleural effusion - Left | 7/689 (1%) | 9 | 3/82 (3.7%) | 3 |
| Pleural effusion - Right | 15/689 (2.2%) | 15 | 3/82 (3.7%) | 3 |
| Regurgitation - Tricuspid-indeterminate +4 | 0/689 (0%) | 0 | 1/82 (1.2%) | 2 |
| Thromboembolic event - Other - Central - No paresis | 0/689 (0%) | 0 | 1/82 (1.2%) | 1 |
| Thromboembolic event - Other - Peripheral - No paresis | 0/689 (0%) | 0 | 1/82 (1.2%) | 1 |
| Thromboembolic event - Stroke | 15/689 (2.2%) | 17 | 3/82 (3.7%) | 3 |
| Thromboembolic event - Transient Ischemic Attack (TIA) | 7/689 (1%) | 9 | 0/82 (0%) | 0 |
| Valve thrombosis - Aortic | 0/689 (0%) | 0 | 1/82 (1.2%) | 1 |
| Gastrointestinal disorders | ||||
| Biliary (gallbladder) | 5/689 (0.7%) | 6 | 1/82 (1.2%) | 2 |
| Endocrine complications | 1/689 (0.1%) | 1 | 0/82 (0%) | 0 |
| Gastrointestinal - Esophageal rupture/tear | 0/689 (0%) | 0 | 1/82 (1.2%) | 1 |
| Gastrointestinal - Infection | 7/689 (1%) | 8 | 1/82 (1.2%) | 1 |
| Gastrointestinal - Other | 20/689 (2.9%) | 25 | 2/82 (2.4%) | 2 |
| Hepatic complication - Other | 3/689 (0.4%) | 3 | 0/82 (0%) | 0 |
| Metabolic complications | 2/689 (0.3%) | 2 | 0/82 (0%) | 0 |
| Pancreatic complication | 3/689 (0.4%) | 3 | 0/82 (0%) | 0 |
| Splenic complication | 1/689 (0.1%) | 1 | 0/82 (0%) | 0 |
| General disorders | ||||
| Cancer - Newly diagnosed | 9/689 (1.3%) | 9 | 1/82 (1.2%) | 1 |
| Cancer - Progression of underlying disease | 4/689 (0.6%) | 4 | 0/82 (0%) | 0 |
| Fever - Unknown origin | 1/689 (0.1%) | 1 | 0/82 (0%) | 0 |
| Nonspecific, unknown, or other body system - Other complication | 43/689 (6.2%) | 51 | 4/82 (4.9%) | 4 |
| NSD - Paravalvular leak +2 Minor | 0/689 (0%) | 0 | 1/82 (1.2%) | 1 |
| NSD - Paravalvular leak +3 Major | 1/689 (0.1%) | 1 | 1/82 (1.2%) | 1 |
| NSD - Paravalvular leak +4 Major | 1/689 (0.1%) | 1 | 0/82 (0%) | 0 |
| Speech disorder | 2/689 (0.3%) | 2 | 0/82 (0%) | 0 |
| SVD - Study valve leaflet tear | 0/689 (0%) | 0 | 1/82 (1.2%) | 1 |
| Vision disorder | 1/689 (0.1%) | 1 | 0/82 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Bone fracture/Break | 8/689 (1.2%) | 9 | 1/82 (1.2%) | 1 |
| Infection/Inflammation - Other | 4/689 (0.6%) | 4 | 0/82 (0%) | 0 |
| Muscular skeletal/Dermatologic - Other | 27/689 (3.9%) | 31 | 5/82 (6.1%) | 5 |
| Sternal wound/Thoracic infection | 13/689 (1.9%) | 14 | 1/82 (1.2%) | 1 |
| Wound infection - Other | 5/689 (0.7%) | 5 | 0/82 (0%) | 0 |
| Psychiatric disorders | ||||
| Psychiatric - Other | 7/689 (1%) | 7 | 1/82 (1.2%) | 1 |
| Psychiatric disorder | 1/689 (0.1%) | 3 | 0/82 (0%) | 0 |
| Renal and urinary disorders | ||||
| Genitourinary - Other | 9/689 (1.3%) | 10 | 1/82 (1.2%) | 1 |
| Renal dysfunction | 0/689 (0%) | 0 | 2/82 (2.4%) | 2 |
| Renal - Other | 5/689 (0.7%) | 6 | 0/82 (0%) | 0 |
| Renal failure - Acute | 8/689 (1.2%) | 9 | 5/82 (6.1%) | 5 |
| Renal failure - Chronic | 1/689 (0.1%) | 1 | 0/82 (0%) | 0 |
| Urinary Tract Infection (UTI) | 4/689 (0.6%) | 4 | 1/82 (1.2%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Hypoxemia | 5/689 (0.7%) | 5 | 0/82 (0%) | 0 |
| Pneumothorax | 14/689 (2%) | 14 | 1/82 (1.2%) | 1 |
| Pulmonary edema | 2/689 (0.3%) | 2 | 0/82 (0%) | 0 |
| Pulmonary embolism - Bilateral | 6/689 (0.9%) | 6 | 0/82 (0%) | 0 |
| Pulmonary hypertension | 1/689 (0.1%) | 1 | 0/82 (0%) | 0 |
| Pulmonary/Respiratory - Other | 8/689 (1.2%) | 8 | 0/82 (0%) | 0 |
| Respiratory dysfunction/Insufficiency | 8/689 (1.2%) | 9 | 1/82 (1.2%) | 1 |
| Respiratory failure - Acute Respiratory Distress Syndrome (ARDS) | 5/689 (0.7%) | 5 | 1/82 (1.2%) | 1 |
| Respiratory failure - COPD | 5/689 (0.7%) | 6 | 2/82 (2.4%) | 2 |
| Respiratory failure - Hemothorax | 0/689 (0%) | 0 | 1/82 (1.2%) | 1 |
| Respiratory failure - Other | 10/689 (1.5%) | 12 | 4/82 (4.9%) | 4 |
| Respiratory failure - Pneumonia | 4/689 (0.6%) | 4 | 2/82 (2.4%) | 2 |
| Respiratory failure - Pneumothorax | 4/689 (0.6%) | 4 | 0/82 (0%) | 0 |
| Respiratory infection - Pneumonia | 7/689 (1%) | 7 | 3/82 (3.7%) | 3 |
| Respiratory infection - Upper (URI) | 2/689 (0.3%) | 2 | 0/82 (0%) | 0 |
| Vascular disorders | ||||
| Vascular - Deep Vein Thrombosis (DVT) | 3/689 (0.4%) | 3 | 1/82 (1.2%) | 1 |
| Vascular - Other | 7/689 (1%) | 9 | 0/82 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Edwards Pericardial Aortic Bioprosthesis, Model 11000A | Edwards Pericardial Mitral Bioprosthesis, Model 11000M | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 542/589 (92%) | 66/82 (80.5%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia - Bleeding related - Major | 11/589 (1.9%) | 11 | 2/82 (2.4%) | 2 |
| Anemia - Bleeding related - Minor | 87/589 (14.8%) | 87 | 18/82 (22%) | 18 |
| Anemia - Non-bleeding related | 61/589 (10.4%) | 61 | 14/82 (17.1%) | 14 |
| Bleeding - Cardiovascular - Major | 2/589 (0.3%) | 2 | 0/82 (0%) | 0 |
| Bleeding - Cardiovascular - Minor | 10/589 (1.7%) | 10 | 0/82 (0%) | 0 |
| Bleeding - Gastrointestinal lower - Minor | 2/589 (0.3%) | 2 | 1/82 (1.2%) | 1 |
| Bleeding - Gastrointestinal upper - Minor | 1/589 (0.2%) | 1 | 0/82 (0%) | 0 |
| Bleeding - Genitourinary - Major | 0/589 (0%) | 0 | 2/82 (2.4%) | 2 |
| Bleeding - Genitourinary - Minor | 4/589 (0.7%) | 4 | 1/82 (1.2%) | 1 |
| Bleeding - Musculoskeletal/Dermatological - Minor (e.g. ecchymosis) | 0/589 (0%) | 0 | 1/82 (1.2%) | 1 |
| Bleeding - Neurological - Major (e.g. CVA) | 1/589 (0.2%) | 1 | 0/82 (0%) | 0 |
| Bleeding - Peripheral vascular - Minor (e.g. nosebleeds; hematomas) | 2/589 (0.3%) | 2 | 2/82 (2.4%) | 2 |
| Bleeding - Pulmonary/Respiratory - Minor (e.g. hemothorax) | 0/589 (0%) | 0 | 1/82 (1.2%) | 1 |
| Blood sepsis | 1/589 (0.2%) | 1 | 1/82 (1.2%) | 1 |
| Blood/Lymphatic - Other | 138/589 (23.4%) | 159 | 14/82 (17.1%) | 20 |
| Thrombocytopenia - Heparin Induced (HIT) | 3/589 (0.5%) | 3 | 2/82 (2.4%) | 2 |
| Thrombocytopenia - Non-heparin induced | 134/589 (22.8%) | 134 | 18/82 (22%) | 18 |
| Cardiac disorders | ||||
| Angina, stable | 5/589 (0.8%) | 5 | 2/82 (2.4%) | 2 |
| Angina, unstable | 1/589 (0.2%) | 1 | 0/82 (0%) | 0 |
| Arrhythmia - Atrial flutter | 10/589 (1.7%) | 10 | 5/82 (6.1%) | 5 |
| Arrhythmia - AV block - 1st degree | 39/589 (6.6%) | 40 | 11/82 (13.4%) | 11 |
| Arrhythmia - AV block - 2nd degree | 7/589 (1.2%) | 7 | 4/82 (4.9%) | 4 |
| Arrhythmia - AV block - 3rd degree | 7/589 (1.2%) | 7 | 2/82 (2.4%) | 2 |
| Arrhythmia - Bradycardia | 17/589 (2.9%) | 19 | 4/82 (4.9%) | 4 |
| Arrhythmia - Bundle branch block - Left | 25/589 (4.2%) | 25 | 0/82 (0%) | 0 |
| Arrhythmia - Bundle branch block - Right | 28/589 (4.8%) | 30 | 3/82 (3.7%) | 3 |
| Arrhythmia - Other | 50/589 (8.5%) | 50 | 8/82 (9.8%) | 8 |
| Arrhythmia - Pacemaker/ICD malfunction | 0/589 (0%) | 0 | 1/82 (1.2%) | 1 |
| Arrhythmia - Paroxysmal Atrial Fibrillation (PAF) | 136/589 (23.1%) | 137 | 12/82 (14.6%) | 12 |
| Arrhythmia - Paroxysmal Atrial Tachycardia (PAT) | 1/589 (0.2%) | 1 | 0/82 (0%) | 0 |
| Arrhythmia - Permanent atrial fibrillation | 1/589 (0.2%) | 1 | 0/82 (0%) | 0 |
| Arrhythmia - Persistent atrial fibrillation | 23/589 (3.9%) | 23 | 3/82 (3.7%) | 3 |
| Arrhythmia - Supraventricular Tachycardia (SVT) | 4/589 (0.7%) | 4 | 1/82 (1.2%) | 1 |
| Arrhythmia - Tachy-bradycardia | 0/589 (0%) | 0 | 1/82 (1.2%) | 1 |
| Arrhythmia - Tachycardia - Non-ventricular | 20/589 (3.4%) | 21 | 1/82 (1.2%) | 1 |
| Arrhythmia - Tachycardia - Ventricular | 16/589 (2.7%) | 16 | 3/82 (3.7%) | 3 |
| Cardiogenic shock | 1/589 (0.2%) | 1 | 2/82 (2.4%) | 2 |
| Cardiovascular - Other | 85/589 (14.4%) | 95 | 13/82 (15.9%) | 16 |
| Heart failure - Acute | 65/589 (11%) | 65 | 2/82 (2.4%) | 2 |
| Heart Failure - Chronic (CHF) | 15/589 (2.5%) | 15 | 1/82 (1.2%) | 1 |
| Hypertension - Pulmonary | 2/589 (0.3%) | 2 | 0/82 (0%) | 0 |
| Hypertension - Systemic | 17/589 (2.9%) | 17 | 2/82 (2.4%) | 2 |
| Hypotension | 38/589 (6.5%) | 40 | 14/82 (17.1%) | 14 |
| Perforation - Other | 1/589 (0.2%) | 1 | 0/82 (0%) | 0 |
| Pericardial effusion - Minor | 21/589 (3.6%) | 21 | 3/82 (3.7%) | 3 |
| Pericarditis | 6/589 (1%) | 6 | 1/82 (1.2%) | 1 |
| Pleural effusion - Bilateral | 13/589 (2.2%) | 13 | 7/82 (8.5%) | 7 |
| Pleural effusion - Left | 10/589 (1.7%) | 10 | 7/82 (8.5%) | 7 |
| Pleural effusion - Right | 1/589 (0.2%) | 1 | 3/82 (3.7%) | 3 |
| Regurgitation - Aortic-central/Transvalvular +3 | 1/589 (0.2%) | 1 | 0/82 (0%) | 0 |
| Regurgitation - Mitral-central/Transvalvular +1 | 0/589 (0%) | 0 | 2/82 (2.4%) | 2 |
| Regurgitation - Mitral-central/Transvalvular +2 | 0/589 (0%) | 0 | 1/82 (1.2%) | 1 |
| Regurgitation - Mitral-central/Transvalvular +3 | 0/589 (0%) | 0 | 1/82 (1.2%) | 1 |
| Regurgitation - Mitral-central/Transvalvular +4 | 1/589 (0.2%) | 1 | 0/82 (0%) | 0 |
| Regurgitation - Mitral-indeterminate +2 | 2/589 (0.3%) | 2 | 0/82 (0%) | 0 |
| Regurgitation - Mitral-indeterminate +3 | 3/589 (0.5%) | 3 | 0/82 (0%) | 0 |
| Regurgitation - Tricuspid-indeterminate +3 | 1/589 (0.2%) | 1 | 0/82 (0%) | 0 |
| Regurgitation - Tricuspid-indeterminate +4 | 0/589 (0%) | 0 | 1/82 (1.2%) | 1 |
| Thromboembolic event - Stroke | 2/589 (0.3%) | 2 | 0/82 (0%) | 0 |
| Thromboembolic event - Transient Ischemic Attack (TIA) | 6/589 (1%) | 6 | 0/82 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Biliary (gallbladder) | 2/589 (0.3%) | 3 | 0/82 (0%) | 0 |
| Endocrine complications | 6/589 (1%) | 6 | 9/82 (11%) | 9 |
| Gastrointestinal - Infection | 7/589 (1.2%) | 7 | 1/82 (1.2%) | 1 |
| Gastrointestinal - Other | 29/589 (4.9%) | 31 | 9/82 (11%) | 9 |
| Hepatic complication - Other | 3/589 (0.5%) | 3 | 0/82 (0%) | 0 |
| Liver Failure - Chronic | 1/589 (0.2%) | 1 | 1/82 (1.2%) | 1 |
| Metabolic complications | 9/589 (1.5%) | 11 | 1/82 (1.2%) | 1 |
| Pancreatic complication | 1/589 (0.2%) | 1 | 1/82 (1.2%) | 1 |
| General disorders | ||||
| Allergic reaction - Medication related | 4/589 (0.7%) | 4 | 0/82 (0%) | 0 |
| Allergic reaction - Other | 0/589 (0%) | 0 | 1/82 (1.2%) | 1 |
| Cancer - Progression of underlying disease | 3/589 (0.5%) | 3 | 0/82 (0%) | 0 |
| Fever - Unknown origin | 4/589 (0.7%) | 4 | 2/82 (2.4%) | 2 |
| Hearing disorder | 0/589 (0%) | 0 | 1/82 (1.2%) | 1 |
| Nonspecific, unknown, or other body system - Other complication | 108/589 (18.3%) | 133 | 14/82 (17.1%) | 21 |
| NSD - Paravalvular leak +1 Minor | 1/589 (0.2%) | 1 | 0/82 (0%) | 0 |
| NSD - Paravalvular leak +2 Minor | 0/589 (0%) | 0 | 2/82 (2.4%) | 2 |
| NSD - Paravalvular leak +3 Major | 3/589 (0.5%) | 3 | 0/82 (0%) | 0 |
| Speech disorder | 1/589 (0.2%) | 1 | 1/82 (1.2%) | 1 |
| Vision disorder | 12/589 (2%) | 14 | 3/82 (3.7%) | 3 |
| Musculoskeletal and connective tissue disorders | ||||
| Bone fracture/Break | 5/589 (0.8%) | 6 | 1/82 (1.2%) | 1 |
| Infection/Inflammation - Other | 11/589 (1.9%) | 11 | 2/82 (2.4%) | 2 |
| Muscular skeletal/Dermatologic - Other | 87/589 (14.8%) | 103 | 10/82 (12.2%) | 12 |
| Sternal wound/Thoracic infection | 9/589 (1.5%) | 9 | 0/82 (0%) | 0 |
| Wound infection - Other | 8/589 (1.4%) | 8 | 1/82 (1.2%) | 1 |
| Psychiatric disorders | ||||
| Psychiatric - Other | 44/589 (7.5%) | 46 | 6/82 (7.3%) | 6 |
| Psychiatric disorder | 6/589 (1%) | 6 | 2/82 (2.4%) | 2 |
| Transient psychotic syndrome | 4/589 (0.7%) | 4 | 0/82 (0%) | 0 |
| Renal and urinary disorders | ||||
| Genitourinary - Other | 22/589 (3.7%) | 24 | 2/82 (2.4%) | 2 |
| Renal - Other | 18/589 (3.1%) | 18 | 1/82 (1.2%) | 1 |
| Renal dysfunction | 10/589 (1.7%) | 11 | 1/82 (1.2%) | 1 |
| Renal failure - Acute | 19/589 (3.2%) | 19 | 4/82 (4.9%) | 4 |
| Renal failure - Chronic | 2/589 (0.3%) | 2 | 0/82 (0%) | 0 |
| Urinary Tract Infection (UTI) | 26/589 (4.4%) | 26 | 6/82 (7.3%) | 9 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Atelectasis | 122/589 (20.7%) | 122 | 10/82 (12.2%) | 10 |
| Hypoxemia | 5/589 (0.8%) | 5 | 2/82 (2.4%) | 2 |
| Pneumothorax | 31/589 (5.3%) | 31 | 3/82 (3.7%) | 3 |
| Pulmonary edema | 26/589 (4.4%) | 26 | 3/82 (3.7%) | 3 |
| Pulmonary embolism - Left | 1/589 (0.2%) | 1 | 0/82 (0%) | 0 |
| Pulmonary embolism - Right | 1/589 (0.2%) | 1 | 1/82 (1.2%) | 1 |
| Pulmonary hypertension | 2/589 (0.3%) | 2 | 1/82 (1.2%) | 1 |
| Pulmonary/Respiratory - Other | 31/589 (5.3%) | 32 | 5/82 (6.1%) | 6 |
| Respiratory dysfunction/Insufficiency | 21/589 (3.6%) | 21 | 1/82 (1.2%) | 1 |
| Respiratory failure - Acute Respiratory Distress Syndrome (ARDS) | 0/589 (0%) | 0 | 1/82 (1.2%) | 1 |
| Respiratory failure - Asthma | 2/589 (0.3%) | 2 | 1/82 (1.2%) | 1 |
| Respiratory failure - COPD | 2/589 (0.3%) | 2 | 0/82 (0%) | 0 |
| Respiratory failure - Other | 13/589 (2.2%) | 14 | 2/82 (2.4%) | 3 |
| Respiratory failure - Pneumonia | 5/589 (0.8%) | 5 | 1/82 (1.2%) | 1 |
| Respiratory failure - Pneumothorax | 5/589 (0.8%) | 5 | 3/82 (3.7%) | 3 |
| Respiratory infection - Pneumonia | 6/589 (1%) | 6 | 1/82 (1.2%) | 1 |
| Respiratory infection - Upper (URI) | 11/589 (1.9%) | 11 | 2/82 (2.4%) | 2 |
| Vascular disorders | ||||
| Vascular - Access site complication | 2/589 (0.3%) | 2 | 0/82 (0%) | 0 |
| Vascular - Deep Vein Thrombosis (DVT) | 4/589 (0.7%) | 4 | 1/82 (1.2%) | 1 |
| Vascular - Other | 19/589 (3.2%) | 19 | 1/82 (1.2%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Publication of overall study results which have not been released requires written approval of Sponsor, but presentation of site-specific results can occur subject to review by Sponsor. Manuscripts will be submitted to Sponsor for review 30 days prior to submission of manuscript for publication/presentation. Sponsor may ask for a 60 day delay of submission of manuscripts for publication to protect proprietary information and filing of related patent applications.
Results Point of Contact
| Name/Title | Andrey Nersesov, Sr. Director of Clinical Affairs, Surgical Structural Heart |
|---|---|
| Organization | Edwards Lifesciences, LLC |
| Phone | 949-250-2500 ext 0225 |
| Andrey_Nersesov@edwards.com |
Responsible Party:
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01757665
Other Study ID Numbers:
- 2012-02
First Posted:
Dec 31, 2012
Last Update Posted:
Jan 26, 2022
Last Verified:
Jan 1, 2022