EDWARDS INTUITY Valve System CADENCE Study
Sponsor
Edwards Lifesciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02688153
Collaborator
(none)
120
1
2
42
2.9
Study Details
Study Description
Brief Summary
The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a randomized study comparing the cross-clamp time (XCT) and cardiopulmonary bypass time (CPBT) of the EDWARDS INTUITY valve system with any commercially available stented aortic bioprosthesis, in patients with logistic EuroSCORE 1 ≥ 6 undergoing elective surgical aortic valve replacement surgery with concomitant coronary bypass grafts.
Additionally, the aim is to gather sufficient data to quantify the effect size of short term patient benefit outcomes previously identified from literature and finally to explore additional healthcare resource utilization or health economic endpoints.
Study Design
Study Type:
Interventional
Actual Enrollment
:
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Comparison of the EDWARDS INTUITY Valve System anD commErcially Available Aortic Bioprostheses in Subjects uNdergoing surgiCal Aortic Valve replacEment
Study Start Date
:
Oct 1, 2012
Actual Primary Completion Date
:
Apr 1, 2016
Actual Study Completion Date
:
Apr 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: EDWARDS INTUITY EDWARDS INTUITY Valve System, Model 8300A |
Device: EDWARDS INTUITY
To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR & CABG.
Other Names:
|
| Active Comparator: Stented aortic bioprostheses Stented aortic bioprostheses |
Device: Stented aortic bioprostheses
In comparison to control valves available on the market.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Average Subject Time Spent on Cardiopulmonary Cross Clamp [At time of surgery, an average of 1.5 hours]
Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.
- Average Amount of Time Subject Spent on Cardiopulmonary Bypass [At time of surgery, an average of 2 hours]
Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.
Secondary Outcome Measures
- Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years. [Baseline and 2 Years]
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.
- Subject's Average Mean Gradients (mmHg) Measurements Over Time. [30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
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 Peak Gradients (mmHg) Measurements Over Time. [30 days, 3 months, 6 months, 1 year, 2 year]
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 Effective Orifice Area (EOA) Measurement Over Time. [30 days, 3 months, 6 months, 1 year, 2 year]
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 Effective Orifice Area Index (EOAI) Measurement Over Time. [30 days, 3 months, 6 months, 1 year, 2 year]
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.
- Amount of Aortic Valvular Regurgitation Over Time. [30 days, 3 months, 6 months, 1 year, 2 year]
Aortic valvular regurgitation occurs when the aortic 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. Aortic 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.
- Conversion of Edwards INTUITY Surgical Aortic Valve to Control During Surgery. [Prior to Surgery]
Subjects randomized to the Edwards INTUITY group that were converted to the control group and received commercially available surgical aortic heart valves during surgery.
- Subjects Who Required a Thoracic Resternotomy Over Time [30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
Number of Subjects who had a surgical opening of their chest after their initial aortic heart valve surgery shown over various time points.
- Subjects Who Received a Permanent Pacemaker Over Time. [30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
Number of Subjects who received a Permanent Pacemaker shown over various time points.
- Subjects With a Major Paravalvular Leak (OPC) Over Time [30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
Number of subjects who experienced a Major Paravalvular Leak (OPC) shown over various time points. 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 0 to 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. A major paravalvular leak (OPC)are any events of leak that required surgical intervention or were considered an serious adverse event.
- Subjects Who Experienced Major Bleeding Over Time. [30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
Number of subjects who experienced Major Bleeding shown over various time points.
- Subjects Who Experienced Respiratory Failure Over Time [30 days, 3 Months , 6 Months, 1 Year, 2 Years.]
Number of subjects who experienced a Respiratory Failure shown over various time points. Respiratory failure happens when not enough oxygen passes from your lungs to your blood.
- Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time [30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
Number of subjects who experienced a Cerebral Vascular Accident or Permanent Stroke shown over various time points.
- Subjects With Renal Failure Over Time [30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
Number of subjects who experienced Renal (kidney) Failure shown over various time points.
- Subjects With Endocarditis Over Time [30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
Number of subjects who experienced Endocarditis shown over various time points. Endocarditis is an infection of the endocardium, which is the inner lining of your heart chambers and heart valves.
- Subjects With a Deep Sternal Would Infection Over Time [30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
Number of subjects who experienced a Deep Sternal Wound Infection shown over various time points.
- Subjects With a Myocardial Infarction Over Time [30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
Number of subjects who experienced a Myocardial Infarction shown over various time points. A Myocardial infarction, commonly known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle.
- Subjects With a Thromboembolism Over Time [30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
Number of subjects who experienced a Thromboembolism shown over various time points. A thromboembolism is an obstruction of a blood vessel by a blood clot that has become dislodged from another site in the circulation.
- Subjects With a Cardiac Tamponade Over Time [30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
Number of subjects who experienced a Cardiac Tamponade shown over various time points. Cardiac tamponade is when fluid in the pericardium (the sac around the heart) builds up and results in compression (squeezing) of the heart.
- Subjects With a Cardiac Reoperation for Any Reason Over Time [30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
Number of subjects who experienced a Cardiac reoperation for any reason shown over various time points.
- Subjects Who Died Intraoperatively [Surgery]
Number of subjects who died during surgery.
- Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time [Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.
- Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time [Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
The Medical Outcomes Study Short-Form 12 (SF-12) - Physical Component Summary (PCS) and Mental Component Summary (MCS). The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status. Subject's Average Score at Baseline and at each follow-up interval until 2 year - SF-12.
- Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time [Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status. Subjects took this questionnaire at baseline, 30 days, 3 Months, 6 Months, 1 Year, and 2 Years.
- Health Care Utilization [Day of surgical procedure through discharge from the hospital, an average of 2 weeks]
The average amount of time the subjects spent in the intensive care unit, the intermediate care length of stay, and the average total length of hospital stay after their heart valve replacement procedure.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion:
-
≥18 years of age
-
aortic stenosis / mixed aortic stenosis and aortic insufficiency
-
SAVR+CABG (1-4 distal anastomoses)
-
Log. EuroSCORE ≥6
-
NYHA Class ≥II
Exclusion (i.a.):
-
pure aortic insufficiency
-
pre-existing prosthetic heart valve or ring
-
congenital true bicuspid / unicuspid aortic valve
-
LVEF <20%
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Bordeaux, Hôpital Haut-Lévêque | Pessac | France | 33604 |
Sponsors and Collaborators
- Edwards Lifesciences
Investigators
- Principal Investigator: Prof. Labrousse, MD, CHU Bordeaux - Hôpital Haut-Lévèque
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- New York Heart Association Classification
- EuroQol Standardized Instrument (EQ-5D) developed to measure of health-related quality of life.
- Short Form Health Survey (SF-12) with 12 questions to measure functional health and well-being of patient's quality of life
Publications
None provided.Responsible Party:
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT02688153
Other Study ID Numbers:
- 2011-11
First Posted:
Feb 23, 2016
Last Update Posted:
Jun 1, 2018
Last Verified:
May 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Edwards Lifesciences
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | All eligible subjects recruited were randomized to each arm/group as 1:1 ratio at start. Amongst randomized arm/group, three of the subjects randomized to the Edwards INTUITY group were converted to the control group and received commercially available surgical aortic heart valves. |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Period Title: Overall Study | ||
| STARTED | 62 | 58 |
| Final Randomized Arm/Group | 59 | 61 |
| COMPLETED | 47 | 51 |
| NOT COMPLETED | 15 | 7 |
Baseline Characteristics
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve | Total |
|---|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. | Total of all reporting groups |
| Overall Participants | 59 | 61 | 120 |
| Overall Participants | 59 | 61 | 120 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
79.4
(4.2)
|
80.0
(4.8)
|
79.7
(4.6)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
24
40.7%
|
19
31.1%
|
43
35.8%
|
| Male |
35
59.3%
|
42
68.9%
|
77
64.2%
|
| Region of Enrollment (Number) [Number] | |||
| Europe |
59
100%
|
61
100%
|
120
100%
|
Outcome Measures
| Title | Average Subject Time Spent on Cardiopulmonary Cross Clamp |
|---|---|
| Description | Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level. |
| Time Frame | At time of surgery, an average of 1.5 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects where data is available. |
| Arm/Group Title | EDWARDS INTUITY Valve System, Model 8300A | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 58 | 61 |
| Median (Full Range) [Minutes] |
77.5
|
82.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | EDWARDS INTUITY Valve System, Model 8300A, Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3660 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | -4.5 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Average Amount of Time Subject Spent on Cardiopulmonary Bypass |
|---|---|
| Description | Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery. |
| Time Frame | At time of surgery, an average of 2 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects where data is available. |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| Median (Full Range) [Minutes] |
109.0
|
107.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | EDWARDS INTUITY Valve System, Model 8300A, Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8377 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | 2 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years. |
|---|---|
| Description | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. |
| Time Frame | Baseline and 2 Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects where data is available. |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 46 | 53 |
| Improved |
40
67.8%
|
43
70.5%
|
| Same |
6
10.2%
|
9
14.8%
|
| Worsend |
0
0%
|
1
1.6%
|
| Title | Subject's Average Mean Gradients (mmHg) Measurements Over Time. |
|---|---|
| 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 | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects where data is available. |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| 30 days |
10.6
(3.9)
|
10.1
(3.6)
|
| 3 months |
10.7
(4.0)
|
11.1
(3.9)
|
| 6 months |
11.7
(4.3)
|
11.4
(4.7)
|
| 1 year |
11.2
(4.1)
|
11.5
(4.4)
|
| 2 year |
10.6
(4.4)
|
11.3
(4.7)
|
| Title | Subject's Average Peak Gradients (mmHg) Measurements Over Time. |
|---|---|
| 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 | 30 days, 3 months, 6 months, 1 year, 2 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects where data is available. |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| 30 days |
19.8
(7.5)
|
18.4
(6.1)
|
| 3 months |
19.5
(7.0)
|
20.2
(7.3)
|
| 6 months |
21.1
(7.2)
|
20.6
(8.2)
|
| 1 year |
20.0
(7.6)
|
20.6
(7.7)
|
| 2 year |
19.5
(7.8)
|
20.4
(8.5)
|
| Title | Subject's Effective Orifice Area (EOA) Measurement Over Time. |
|---|---|
| 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 | 30 days, 3 months, 6 months, 1 year, 2 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects where data is available. |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| 30 days |
1.7
(0.5)
|
1.6
(0.4)
|
| 3 months |
1.8
(0.6)
|
1.6
(0.3)
|
| 6 months |
1.7
(0.5)
|
1.6
(0.4)
|
| 1 year |
1.7
(0.4)
|
1.5
(0.4)
|
| 2 year |
1.7
(0.5)
|
1.5
(0.4)
|
| Title | Subject's Effective Orifice Area Index (EOAI) Measurement Over Time. |
|---|---|
| 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 | 30 days, 3 months, 6 months, 1 year, 2 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects where data is available. |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| 30 days |
1.0
(0.3)
|
0.9
(0.2)
|
| 3 months |
1.0
(0.3)
|
0.9
(0.2)
|
| 6 months |
0.9
(0.3)
|
0.9
(0.2)
|
| 1 year |
0.9
(0.2)
|
0.8
(0.2)
|
| 2 year |
0.9
(0.3)
|
0.8
(0.2)
|
| Title | Amount of Aortic Valvular Regurgitation Over Time. |
|---|---|
| Description | Aortic valvular regurgitation occurs when the aortic 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. Aortic 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 | 30 days, 3 months, 6 months, 1 year, 2 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported for subjects where data is available. |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| 0 None |
30
50.8%
|
38
62.3%
|
| +1 Trivial/Trace |
12
20.3%
|
13
21.3%
|
| +2 Mild |
1
1.7%
|
0
0%
|
| +3 Moderate |
1
1.7%
|
0
0%
|
| +4 Severe |
0
0%
|
0
0%
|
| 0 None |
30
50.8%
|
41
67.2%
|
| +1 Trivial/Trace |
11
18.6%
|
7
11.5%
|
| +2 Mild |
0
0%
|
0
0%
|
| +3 Moderate |
2
3.4%
|
0
0%
|
| +4 Severe |
0
0%
|
0
0%
|
| 0 None |
27
45.8%
|
39
63.9%
|
| +1 Trivial/Trace |
9
15.3%
|
11
18%
|
| +2 Mild |
4
6.8%
|
0
0%
|
| +3 Moderate |
1
1.7%
|
0
0%
|
| +4 Severe |
0
0%
|
0
0%
|
| 0 None |
30
50.8%
|
40
65.6%
|
| +1 Trivial/Trace |
8
13.6%
|
8
13.1%
|
| +2 Mild |
1
1.7%
|
1
1.6%
|
| +3 Moderate |
1
1.7%
|
0
0%
|
| +4 Severe |
0
0%
|
0
0%
|
| 0 None |
31
52.5%
|
44
72.1%
|
| +1 Trivial/Trace |
8
13.6%
|
4
6.6%
|
| +2 Mild |
0
0%
|
0
0%
|
| +3 Moderate |
1
1.7%
|
0
0%
|
| +4 Severe |
0
0%
|
0
0%
|
| Title | Conversion of Edwards INTUITY Surgical Aortic Valve to Control During Surgery. |
|---|---|
| Description | Subjects randomized to the Edwards INTUITY group that were converted to the control group and received commercially available surgical aortic heart valves during surgery. |
| Time Frame | Prior to Surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| Original number of subjects randomized to each arm/group. |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 62 | 58 |
| Count of Participants [Participants] |
3
5.1%
|
0
0%
|
| Title | Subjects Who Required a Thoracic Resternotomy Over Time |
|---|---|
| Description | Number of Subjects who had a surgical opening of their chest after their initial aortic heart valve surgery shown over various time points. |
| Time Frame | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cumulative number of subjects with an event by each time point |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| 30 days |
6
10.2%
|
8
13.1%
|
| 3 months |
6
10.2%
|
8
13.1%
|
| 6 months |
6
10.2%
|
8
13.1%
|
| 1 year |
7
11.9%
|
8
13.1%
|
| 2 year |
7
11.9%
|
8
13.1%
|
| Title | Subjects Who Received a Permanent Pacemaker Over Time. |
|---|---|
| Description | Number of Subjects who received a Permanent Pacemaker shown over various time points. |
| Time Frame | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cumulative number of subjects with an event by each time point |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| 30 days |
1
1.7%
|
4
6.6%
|
| 3 months |
1
1.7%
|
5
8.2%
|
| 6 months |
1
1.7%
|
6
9.8%
|
| 1 year |
1
1.7%
|
6
9.8%
|
| 2 year |
1
1.7%
|
6
9.8%
|
| Title | Subjects With a Major Paravalvular Leak (OPC) Over Time |
|---|---|
| Description | Number of subjects who experienced a Major Paravalvular Leak (OPC) shown over various time points. 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 0 to 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. A major paravalvular leak (OPC)are any events of leak that required surgical intervention or were considered an serious adverse event. |
| Time Frame | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cumulative number of subjects with an event by each time point |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| 30 days |
1
1.7%
|
0
0%
|
| 3 months |
1
1.7%
|
0
0%
|
| 6 months |
1
1.7%
|
0
0%
|
| 1 year |
1
1.7%
|
0
0%
|
| 2 year |
1
1.7%
|
0
0%
|
| Title | Subjects Who Experienced Major Bleeding Over Time. |
|---|---|
| Description | Number of subjects who experienced Major Bleeding shown over various time points. |
| Time Frame | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cumulative number of subjects with an event by each time point |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| 30 days |
12
20.3%
|
16
26.2%
|
| 3 months |
13
22%
|
17
27.9%
|
| 6 months |
15
25.4%
|
17
27.9%
|
| 1 year |
15
25.4%
|
18
29.5%
|
| 2 year |
15
25.4%
|
19
31.1%
|
| Title | Subjects Who Experienced Respiratory Failure Over Time |
|---|---|
| Description | Number of subjects who experienced a Respiratory Failure shown over various time points. Respiratory failure happens when not enough oxygen passes from your lungs to your blood. |
| Time Frame | 30 days, 3 Months , 6 Months, 1 Year, 2 Years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cumulative number of subjects with an event by each time point |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| 30 days |
3
5.1%
|
1
1.6%
|
| 3 months |
3
5.1%
|
1
1.6%
|
| 6 months |
3
5.1%
|
1
1.6%
|
| 1 year |
3
5.1%
|
1
1.6%
|
| 2 year |
3
5.1%
|
1
1.6%
|
| Title | Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time |
|---|---|
| Description | Number of subjects who experienced a Cerebral Vascular Accident or Permanent Stroke shown over various time points. |
| Time Frame | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cumulative number of subjects with an event by each time point |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| 30 days |
0
0%
|
0
0%
|
| 3 months |
0
0%
|
1
1.6%
|
| 6 months |
0
0%
|
2
3.3%
|
| 1 year |
1
1.7%
|
2
3.3%
|
| 2 year |
1
1.7%
|
2
3.3%
|
| Title | Subjects With Renal Failure Over Time |
|---|---|
| Description | Number of subjects who experienced Renal (kidney) Failure shown over various time points. |
| Time Frame | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cumulative number of subjects with an event by each time point |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| 30 days |
2
3.4%
|
1
1.6%
|
| 3 months |
2
3.4%
|
1
1.6%
|
| 6 months |
2
3.4%
|
1
1.6%
|
| 1 year |
2
3.4%
|
1
1.6%
|
| 2 year |
2
3.4%
|
1
1.6%
|
| Title | Subjects With Endocarditis Over Time |
|---|---|
| Description | Number of subjects who experienced Endocarditis shown over various time points. Endocarditis is an infection of the endocardium, which is the inner lining of your heart chambers and heart valves. |
| Time Frame | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cumulative number of subjects with an event by each time point |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| 30 days |
0
0%
|
0
0%
|
| 3 months |
0
0%
|
0
0%
|
| 6 months |
0
0%
|
1
1.6%
|
| 1 year |
1
1.7%
|
1
1.6%
|
| 2 year |
1
1.7%
|
1
1.6%
|
| Title | Subjects With a Deep Sternal Would Infection Over Time |
|---|---|
| Description | Number of subjects who experienced a Deep Sternal Wound Infection shown over various time points. |
| Time Frame | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cumulative number of subjects with an event by each time point |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| 30 days |
0
0%
|
0
0%
|
| 3 months |
1
1.7%
|
0
0%
|
| 6 months |
1
1.7%
|
0
0%
|
| 1 year |
1
1.7%
|
0
0%
|
| 2 year |
1
1.7%
|
0
0%
|
| Title | Subjects With a Myocardial Infarction Over Time |
|---|---|
| Description | Number of subjects who experienced a Myocardial Infarction shown over various time points. A Myocardial infarction, commonly known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle. |
| Time Frame | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cumulative number of subjects with an event by each time point |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| 30 days |
2
3.4%
|
0
0%
|
| 3 months |
2
3.4%
|
1
1.6%
|
| 6 months |
3
5.1%
|
1
1.6%
|
| 1 year |
3
5.1%
|
1
1.6%
|
| 2 year |
3
5.1%
|
1
1.6%
|
| Title | Subjects With a Thromboembolism Over Time |
|---|---|
| Description | Number of subjects who experienced a Thromboembolism shown over various time points. A thromboembolism is an obstruction of a blood vessel by a blood clot that has become dislodged from another site in the circulation. |
| Time Frame | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cumulative number of subjects with an event by each time point |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| 30 days |
2
3.4%
|
0
0%
|
| 3 months |
2
3.4%
|
2
3.3%
|
| 6 months |
3
5.1%
|
3
4.9%
|
| 1 year |
4
6.8%
|
4
6.6%
|
| 2 year |
5
8.5%
|
4
6.6%
|
| Title | Subjects With a Cardiac Tamponade Over Time |
|---|---|
| Description | Number of subjects who experienced a Cardiac Tamponade shown over various time points. Cardiac tamponade is when fluid in the pericardium (the sac around the heart) builds up and results in compression (squeezing) of the heart. |
| Time Frame | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cumulative number of subjects with an event by each time point |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| 30 days |
3
5.1%
|
2
3.3%
|
| 3 months |
3
5.1%
|
2
3.3%
|
| 6 months |
3
5.1%
|
2
3.3%
|
| 1 year |
3
5.1%
|
2
3.3%
|
| 2 year |
3
5.1%
|
2
3.3%
|
| Title | Subjects With a Cardiac Reoperation for Any Reason Over Time |
|---|---|
| Description | Number of subjects who experienced a Cardiac reoperation for any reason shown over various time points. |
| Time Frame | 30 days, 3 Months, 6 Months, 1 Year, 2 Years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cumulative number of subjects with an event by each time point |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| 30 days |
6
10.2%
|
9
14.8%
|
| 3 months |
6
10.2%
|
11
18%
|
| 6 months |
9
15.3%
|
12
19.7%
|
| 1 year |
10
16.9%
|
12
19.7%
|
| 2 year |
10
16.9%
|
13
21.3%
|
| Title | Subjects Who Died Intraoperatively |
|---|---|
| Description | Number of subjects who died during surgery. |
| Time Frame | Surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects who died during surgery |
| Arm/Group Title | EDWARDS INTUITY Valve System, Model 8300A | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time |
|---|---|
| Description | The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems. |
| Time Frame | Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported where data is available. |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| Baseline |
0.773
(0.155)
|
0.723
(0.186)
|
| 30 day |
0.790
(0.180)
|
0.771
(0.189)
|
| 3 month |
0.850
(0.179)
|
0.808
(0.200)
|
| 6 month |
0.877
(0.136)
|
0.827
(0.206)
|
| 1 year |
0.831
(0.172)
|
0.803
(0.212)
|
| 2 year |
0.864
(0.160)
|
0.835
(0.198)
|
| Title | Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time |
|---|---|
| Description | The Medical Outcomes Study Short-Form 12 (SF-12) - Physical Component Summary (PCS) and Mental Component Summary (MCS). The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status. Subject's Average Score at Baseline and at each follow-up interval until 2 year - SF-12. |
| Time Frame | Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported where data is available. |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| PCS -Baseline |
40.67
(7.83)
|
39.47
(7.25)
|
| PCS -30 day |
40.57
(7.88)
|
41.16
(7.02)
|
| PCS -3 month |
44.17
(8.77)
|
43.73
(8.61)
|
| PCS -6 month |
45.87
(6.96)
|
46.00
(8.47)
|
| PCS -1 year |
45.40
(8.09)
|
46.01
(8.52)
|
| PCS -2 year |
44.74
(7.92)
|
44.02
(8.35)
|
| MCS -Baseline |
47.30
(10.49)
|
44.91
(11.16)
|
| MCS -30 day |
48.01
(10.63)
|
44.85
(11.92)
|
| MCS -3 month |
49.56
(10.03)
|
48.93
(9.46)
|
| MCS -6 month |
50.64
(9.71)
|
48.45
(10.10)
|
| MCS -1 year |
51.08
(9.38)
|
49.52
(10.09)
|
| MCS -2 year |
51.65
(9.97)
|
50.62
(9.64)
|
| Title | Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time |
|---|---|
| Description | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status. Subjects took this questionnaire at baseline, 30 days, 3 Months, 6 Months, 1 Year, and 2 Years. |
| Time Frame | Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome is reported where data is available. |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| Baseline |
64.50
(21.95)
|
57.50
(20.98)
|
| 30 day |
71.44
(22.69)
|
69.24
(21.83)
|
| 3 month |
83.20
(16.26)
|
78.26
(20.20)
|
| 6 month |
85.05
(15.71)
|
78.74
(21.33)
|
| 1 year |
82.81
(14.86)
|
80.26
(21.28)
|
| 2 year |
83.12
(18.62)
|
79.31
(20.33)
|
| Title | Health Care Utilization |
|---|---|
| Description | The average amount of time the subjects spent in the intensive care unit, the intermediate care length of stay, and the average total length of hospital stay after their heart valve replacement procedure. |
| Time Frame | Day of surgical procedure through discharge from the hospital, an average of 2 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| This outcome is reported for subjects where data is available. |
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Arm/Group Description | Subject who received an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. |
| Measure Participants | 59 | 61 |
| Length of stay |
12.0
(7.2)
|
10.5
(5.3)
|
| ICU Length of stay |
3.9
(4.2)
|
2.9
(1.9)
|
| Intermediate care length of stay |
1.2
(1.9)
|
1.2
(1.4)
|
Adverse Events
| Time Frame | Events occurring from baseline through two years post implant | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve | ||
| Arm/Group Description | Subject who receive an Edwards INTUITY surgical aortic heart valve. | Subject who received a commercially available surgical aortic heart valve. | ||
All Cause Mortality |
||||
| Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/59 (11.9%) | 5/61 (8.2%) | ||
Serious Adverse Events |
||||
| Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 42/59 (71.2%) | 38/61 (62.3%) | ||
| Blood and lymphatic system disorders | ||||
| Bleeding - cardiovascular - Major | 5/59 (8.5%) | 9/61 (14.8%) | ||
| Bleeding - Neurological - Major (e.g. CVA) | 0/59 (0%) | 2/61 (3.3%) | ||
| ANEMIA - BLEEDING RELATED - MINOR | 1/59 (1.7%) | 1/61 (1.6%) | ||
| ANEMIA - NON-BLEEDING RELATED | 1/59 (1.7%) | 1/61 (1.6%) | ||
| BLOOD SEPSIS | 2/59 (3.4%) | 0/61 (0%) | ||
| BLEEDING - MUSCULOSKELETAL/DERMATOLOGICAL -MAJOR (E.G. ECCHYMOSIS) | 0/59 (0%) | 1/61 (1.6%) | ||
| BLEEDING - PERIPHERAL VASCULAR - MINOR (E.G. NOSEBLEEDS; HEMATOMAS) | 0/59 (0%) | 1/61 (1.6%) | ||
| BLEEDING - PERIPHERAL VASCULAR -MAJOR (E.G. NOSEBLEEDS; HEMATOMAS) | 1/59 (1.7%) | 0/61 (0%) | ||
| BLEEDING - GASTROINTESTINAL UPPER -MAJOR | 1/59 (1.7%) | 0/61 (0%) | ||
| BLEEDING - NEUROLOGICAL - MINOR (E.G. CVA) | 1/59 (1.7%) | 0/61 (0%) | ||
| THROMBOCYTOPENIA - HEPARIN INDUCED (HIT) | 1/59 (1.7%) | 0/61 (0%) | ||
| Cardiac disorders | ||||
| THROMBOEMBOLIC EVENT - STROKE | 1/59 (1.7%) | 1/61 (1.6%) | ||
| THROMBOEMBOLIC EVENT - OTHER - PERIPHERAL - NO PARESIS | 1/59 (1.7%) | 0/61 (0%) | ||
| ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF) | 3/59 (5.1%) | 4/61 (6.6%) | ||
| ARRHYTHMIA - AV BLOCK - 1ST DEGREE | 1/59 (1.7%) | 0/61 (0%) | ||
| ARRHYTHMIA - AV BLOCK - 3RD DEGREE | 1/59 (1.7%) | 4/61 (6.6%) | ||
| ARRHYTHMIA - BRADYCARDIA | 1/59 (1.7%) | 1/61 (1.6%) | ||
| ARRHYTHMIA - BUNDLE BRANCH BLOCK - LEFT | 0/59 (0%) | 1/61 (1.6%) | ||
| ARRHYTHMIA - PERSISTANT ATRIAL FIBRILLAITON | 2/59 (3.4%) | 1/61 (1.6%) | ||
| ARRHYTHMIA - PERMANENT ATRIAL FIBRILLATION | 1/59 (1.7%) | 0/61 (0%) | ||
| ARRHYTHMIA - TACHYCARDIA - VENTRICULAR | 1/59 (1.7%) | 0/61 (0%) | ||
| ANGINA, STABLE | 0/59 (0%) | 2/61 (3.3%) | ||
| ANGINA, UNSTABLE | 2/59 (3.4%) | 2/61 (3.3%) | ||
| CARDIAC DECOMPENSATION | 5/59 (8.5%) | 1/61 (1.6%) | ||
| CARDIAC ARREST | 2/59 (3.4%) | 0/61 (0%) | ||
| CARDIOVASCULAR - OTHER | 1/59 (1.7%) | 1/61 (1.6%) | ||
| CARDIOGENIC SHOCK | 1/59 (1.7%) | 0/61 (0%) | ||
| HEART FAILURE - ACUTE | 1/59 (1.7%) | 2/61 (3.3%) | ||
| HEART FAILURE - CHRONIC (CHF) | 1/59 (1.7%) | 1/61 (1.6%) | ||
| CORONARY ARTERY OSTIAL OBSTRUCTION | 0/59 (0%) | 1/61 (1.6%) | ||
| ENDOCARDITIS | 1/59 (1.7%) | 1/61 (1.6%) | ||
| HYPOTENSION | 0/59 (0%) | 1/61 (1.6%) | ||
| MYOCARDIAL INFARCTION | 1/59 (1.7%) | 1/61 (1.6%) | ||
| PERICARDIAL EFFUSION - MAJOR | 1/59 (1.7%) | 0/61 (0%) | ||
| HYPERTENSION - SYSTEMIC | 0/59 (0%) | 2/61 (3.3%) | ||
| PERICARDIAL TAMPONADE - MAJOR | 2/59 (3.4%) | 0/61 (0%) | ||
| REGURGITATION - AORTIC-CENTRAL/TRANSVALVULAR-+4 | 1/59 (1.7%) | 0/61 (0%) | ||
| Gastrointestinal disorders | ||||
| GASTROINTESTINAL - INFECTION | 0/59 (0%) | 2/61 (3.3%) | ||
| GASTROINTESTINAL - OTHER | 3/59 (5.1%) | 4/61 (6.6%) | ||
| General disorders | ||||
| NSD - PARAVALVULAR LEAK - +2 | 1/59 (1.7%) | 0/61 (0%) | ||
| NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION | 3/59 (5.1%) | 6/61 (9.8%) | ||
| CANCER - NEWLY DIAGNOSED | 1/59 (1.7%) | 1/61 (1.6%) | ||
| ANAPHYLACTIC REACTION | 0/59 (0%) | 1/61 (1.6%) | ||
| MULTI-SYSTEM ORGAN FAILURE | 0/59 (0%) | 1/61 (1.6%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| MUSCULAR SKELETAL / DERMATOLOGIC - OTHER | 5/59 (8.5%) | 3/61 (4.9%) | ||
| BONE FRACTURE/BREAK | 3/59 (5.1%) | 2/61 (3.3%) | ||
| STERNAL WOUND/THORACIC INFECTION | 1/59 (1.7%) | 0/61 (0%) | ||
| Renal and urinary disorders | ||||
| RENAL FAILURE - ACUTE | 3/59 (5.1%) | 2/61 (3.3%) | ||
| RENAL DYSFUNCTION | 0/59 (0%) | 1/61 (1.6%) | ||
| GENITOURINARY - OTHER | 0/59 (0%) | 1/61 (1.6%) | ||
| URINARY TRACT INFECTION (UTI) | 0/59 (0%) | 1/61 (1.6%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| PLEURAL EFFUSION - LEFT | 5/59 (8.5%) | 2/61 (3.3%) | ||
| RESPIRATORY INFECTION - PNEUMONIA | 1/59 (1.7%) | 2/61 (3.3%) | ||
| HYPOXEMIA | 0/59 (0%) | 1/61 (1.6%) | ||
| PLEURAL EFFUSION - RIGHT | 0/59 (0%) | 1/61 (1.6%) | ||
| RESPIRATORY FAILURE -OTHER | 2/59 (3.4%) | 1/61 (1.6%) | ||
| RESPIRATORY FAILURE -ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) | 2/59 (3.4%) | 0/61 (0%) | ||
| ATELECTASIS | 1/59 (1.7%) | 0/61 (0%) | ||
| PULMONARY EDEMA | 1/59 (1.7%) | 0/61 (0%) | ||
| RESPIRATORY DYSFUNCTION/INSUFFICIENCY | 1/59 (1.7%) | 0/61 (0%) | ||
| RESPIRATORY FAILURE -COPD | 1/59 (1.7%) | 0/61 (0%) | ||
| Vascular disorders | ||||
| VASCULAR - OTHER | 2/59 (3.4%) | 2/61 (3.3%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 46/59 (78%) | 43/61 (70.5%) | ||
| Blood and lymphatic system disorders | ||||
| ANEMIA - NON-BLEEDING RELATED | 10/59 (16.9%) | 7/61 (11.5%) | ||
| ANEMIA - BLEEDING RELATED - MINOR | 6/59 (10.2%) | 0/61 (0%) | ||
| BLEEDING - CARDIOVASCULAR - MINOR | 5/59 (8.5%) | 4/61 (6.6%) | ||
| Cardiac disorders | ||||
| ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF) | 14/59 (23.7%) | 14/61 (23%) | ||
| ARRHYTHMIA - AV BLOCK - 1ST DEGREE | 0/59 (0%) | 7/61 (11.5%) | ||
| ARRHYTHMIA - BUNDLE BRANCH BLOCK - LEFT | 5/59 (8.5%) | 0/61 (0%) | ||
| ARRHYTHMIA - BUNDLE BRANCH BLOCK - RIGHT | 4/59 (6.8%) | 0/61 (0%) | ||
| ARRHYTHMIA - PERSISTANT ATRIAL FIBRILLAITON | 3/59 (5.1%) | 6/61 (9.8%) | ||
| HYPOTENSION | 5/59 (8.5%) | 0/61 (0%) | ||
| PERICARDIAL EFFUSION - MINOR | 4/59 (6.8%) | 0/61 (0%) | ||
| CARDIOVASCULAR - OTHER | 0/59 (0%) | 4/61 (6.6%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| MUSCULAR SKELETAL / DERMATOLOGIC - OTHER | 0/59 (0%) | 5/61 (8.2%) | ||
| Psychiatric disorders | ||||
| PSYCHIATRIC DISORDER | 3/59 (5.1%) | 0/61 (0%) | ||
| Renal and urinary disorders | ||||
| URINARY TRACT INFECTION (UTI) | 7/59 (11.9%) | 9/61 (14.8%) | ||
| RENAL DYSFUNCTION | 5/59 (8.5%) | 0/61 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| RESPIRATORY INFECTION - PNEUMONIA | 3/59 (5.1%) | 0/61 (0%) | ||
| RESPIRATORY INFECTION - UPPER (URI) | 3/59 (5.1%) | 0/61 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
PI can't publish/present on overall study results not yet published but may publish his own data subject to EW review prior to submission/presentation, but data analyses of site-specific results can occur only in intervals as specified in the CTA. Publication/presentation of the PI's site-specific results of devices which haven't been market released and which still may be undergoing development, shall not include claims of device safety/effectiveness and will require the review/approval of EW.
Results Point of Contact
| Name/Title | Mary Edwards, VP Clinical and Regulatory Affairs, HVT |
|---|---|
| Organization | Edwards Lifesciences, LLC |
| Phone | 949-250-2500 ext 1536 |
| mary_edwards@edwards.com |
Responsible Party:
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT02688153
Other Study ID Numbers:
- 2011-11
First Posted:
Feb 23, 2016
Last Update Posted:
Jun 1, 2018
Last Verified:
May 1, 2018