Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

• Sponsor: Edwards Lifesciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01651052
• Collaborator: (none)
• Enrollment: 133
• Locations: 2
• Arm: 1
• Duration (Months): 84
• Patients Per Site: 66.5
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Disorder; Aortic Valve Insufficiency; Aortic Valve Stenosis; Heart Failure; Coronary Artery Disease	Procedure: Heart Valve Surgery	N/A

Detailed Description

This is a prospective, non-randomized, non-controlled observational clinical trial. Up to 200 subjects will be enrolled at up to 6 participating clinical sites. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic valve. Patients will be followed and assessed after implant for up to 5 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 133 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Jul 1, 2018
• Actual Study Completion Date: Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aortic Bioprosthesis, Model 11000 Aortic valve replacement therapy	Procedure: Heart Valve Surgery; Implant of an aortic valve, Model 11000

Outcome Measures

Primary Outcome Measures

1. Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) [Events occurring within 30 days of procedure]

   Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100

2. Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) [Events occurring >= 31 days and up through 5 years post-implant]

   Number of late events divided by the total number of late patient years x 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).

Secondary Outcome Measures

1. Subject's Average Mean Gradient Measurements [Baseline through 5-Year (at each scheduled follow-up visit)]

   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.

2. Subject's Average Effective Orifice Area Measurements [Baseline through 5-Year (at each scheduled follow-up visit)]

   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.

3. Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline. [3-6 Months and 1 through 5 Years compared to baseline]

   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.

4. Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey [Baseline and one year follow-up]

   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.

5. Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time [Baseline and 1 Year]

   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.

Other Outcome Measures

1. Subject's Average White Blood Cell Count [Baseline, 3-6 Months, and 1 through 5 Years]

   Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.

2. Subject's Average Red Blood Cells Count [Baseline, 3-6 Months, and 1 through 5 Years]

   Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.

3. Subject's Average Hemoglobin Count [Baseline, 3-6 months, and 1 through 5 years]

   Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.

4. Subject's Average Hematocrit Percentage [Baseline, 3-6 Months, and 1 through 5 Years]

   Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component(plasma) in the blood.

5. Subject's Average Platelet Count [Baseline, 3-6 Months, and 1 through 5 Years]

   Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.

6. Subject's Average Plasma Free Hemoglobin [Baseline, 3-6 Months, and 1 through 5 Years]

   Laboratory Analysis of Plasma Free Hemoglobin on blood drawn from subjects. This blood test measures the level of free hemoglobin in the liquid part of the blood (the serum).

7. Subject's Average Serum Creatinine [Baseline]

   Laboratory Analysis of Serum Creatinine on blood drawn from subjects. Creatinine blood test is a test that measures kidney function.

8. Subject's Average International Normalized Ratio [Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years]

   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 liquid portion (plasma) of the blood to clot.

9. Subject's Average Partial Thromboplastin Time [Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years]

   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.

10. Subject's Average Prothrombin Time [Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 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 liquid portion (plasma) of the blood to clot.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years or older

• Require replacement of aortic valve

• Signed informed consent

• Willing to return to study site for follow-up visits

Exclusion Criteria:

• Active endocarditis/myocarditis (< 3 months)

• Myocardial infarction (< 30 days)

• Renal insufficiency/ End-stage renal disease

• Life expectancy (< 1 year)

• Requires multiple valve replacement/repair

• Requiring emergent aortic valve surgery

• Pregnant or lactating

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Krakowski Szpital Specjalistyczny im. Jana Pawła II	Kraków		Poland	31-202
2	Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego	Warsaw		Poland	04-628

Sponsors and Collaborators

• Edwards Lifesciences

Investigators

• Principal Investigator: Jerzy Sadowski, MD, John Paul II Hospital
• Principal Investigator: Jacek Rozanski, MD, The Cardinal Stefan Wyszyński Institute of Cardiology

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 8, 2012

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

• De La Fuente AB, Wright GA, Olin JM, Duhay FG, Kapelak B, Bochenek M, Bartus K, Sadowski J. Advanced Integrity Preservation Technology Reduces Bioprosthesis Calcification While Preserving Performance and Safety. J Heart Valve Dis. 2015 Jan;24(1):101-9.

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT01651052
• Other Study ID Numbers: 2010-03
• First Posted: Jul 26, 2012
• Last Update Posted: Jul 26, 2019
• Last Verified: Jul 1, 2019

• Keywords provided by Edwards Lifesciences: Aortic valve replacement/regurgitation
• Additional relevant MeSH terms: Coronary Artery Disease; Aortic Valve Stenosis; Aortic Valve Insufficiency; Aortic Valve Disease

Study Results

Participant Flow

Pre-assignment Detail	133 Subjects were enrolled and implanted with the study valve, for which data is available.

Arm/Group Title	Aortic Bioprosthesis, Model 11000
Arm/Group Description	Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000
Period Title: Overall Study
STARTED	133
Study Valve Group	133
COMPLETED	107
NOT COMPLETED	26

Baseline Characteristics

Arm/Group Title	Aortic Bioprosthesis, Model 11000
Arm/Group Description	Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000
Overall Participants	133
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	65.3 (13.5)
Sex: Female, Male (Count of Participants)
Female	68 51.1%
Male	65 48.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	113 85%
Unknown or Not Reported	20 15%
Region of Enrollment (Count of Participants)
Poland	133 100%

Outcome Measures

1. Primary Outcome

Title	Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
Description	Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100
Time Frame	Events occurring within 30 days of procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aortic Bioprosthesis, Model 11000
Arm/Group Description	Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000
Measure Participants	133
All Cause Mortality	2.3
Trial valve-related Mortality	0.8
Study Valve Related Reoperation	0.0
Explant	0.0
Thromboembolism	2.3
Valve Thrombosis	0.0
Bleeding Event	8.3
Major Bleeding Event	6.8
Paravalvular Leak (PVL)	0.8
Major Paravalvular Leak	0.0
Endocarditis	0.0
Hemolysis	0.0
Nonstructural Valve Dysfunction (Not PVL)	0.0
Structural Valve Deterioration	0.0

2. Primary Outcome

Title	Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Description	Number of late events divided by the total number of late patient years x 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 5 years post-implant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aortic Bioprosthesis, Model 11000
Arm/Group Description	Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000
Measure Participants	133
All Cause Mortality	3.2
Trial valve-related mortality	0.7
Study Valve Related Reoperation	0.2
Explant	0.2
Thromboembolism	0.4
Valve Thrombosis	0.2
Bleeding Event	0.4
Major Bleeding Event	0.4
Paravalvular Leak (PVL)	0.0
Major Paravalvular Leak	0.0
Endocarditis	0.2
Hemolysis	0.0
Nonstructural Valve Dysfunction (Not PVL)	0.2
Structural Valve Deterioration	0.0

3. Secondary Outcome

Title	Subject's Average Mean Gradient Measurements
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	Baseline through 5-Year (at each scheduled follow-up visit)

Outcome Measure Data

Analysis Population Description

This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.

Arm/Group Title	Aortic Bioprosthesis, Model 11000
Arm/Group Description	Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000
Measure Participants	133
Baseline	49.4 (21.7)
Discharge	12.3 (5.3)
3-6 months	12.2 (5.9)
1 year	13.9 (6.1)
2 year	13.8 (6.4)
3 year	14.3 (6.1)
4 year	15.0 (7.2)
5 year	14.8 (7.6)

4. Secondary Outcome

Title	Subject's Average Effective Orifice Area Measurements
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	Baseline through 5-Year (at each scheduled follow-up visit)

Outcome Measure Data

Analysis Population Description

This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.

Arm/Group Title	Aortic Bioprosthesis, Model 11000
Arm/Group Description	Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000
Measure Participants	133
Baseline	1.0 (0.8)
Discharge	2.0 (0.6)
3-6 Month	1.8 (0.5)
1 Year	1.8 (0.6)
2 Year	1.6 (0.5)
3 Year	1.5 (0.5)
4 Year	1.5 (0.4)
5 Year	1.4 (0.5)

5. Secondary Outcome

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. 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	3-6 Months and 1 through 5 Years compared to baseline

Outcome Measure Data

Analysis Population Description

This outcome is reported for subjects who received the Model 11000 surgical aortic heart valve where data is available.

Arm/Group Title	Aortic Bioprosthesis, Model 11000
Arm/Group Description	Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000
Measure Participants	133
Improve at 3-6 Months	89 66.9%
Same at 3-6 Months	36 27.1%
Worse at 3-6 months	3 2.3%
Improve at 1 Year	68 51.1%
Same at 1 Year	48 36.1%
Worse at 1 Year	6 4.5%
Improve at 2 Years	68 51.1%
Same at 2 Years	34 25.6%
Worse at 2 Years	9 6.8%
Improve at 3 Years	59 44.4%
Same at 3 Years	41 30.8%
Worse at 3 Years	5 3.8%
Improve at 4 Years	55 41.4%
Same at 4 Years	40 30.1%
Worse at 4 Years	6 4.5%
Improve at 5 Years	50 37.6%
Same at 5 Years	33 24.8%
Worse at 5 Years	8 6%

6. Secondary Outcome

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 follow-up

Outcome Measure Data

Analysis Population Description

This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.

Arm/Group Title	Aortic Bioprosthesis, Model 11000
Arm/Group Description	Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000
Measure Participants	56
Physical Health - Baseline	42.5 (10.2)
Physical Health - 1 Year follow-up	49 (7.4)
Mental Health - Baseline	50.2 (8.6)
Mental Health - 1 Year follow-up	51.2 (7.3)

7. Secondary Outcome

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 and 1 Year

Outcome Measure Data

Analysis Population Description

This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.

Arm/Group Title	Aortic Bioprosthesis, Model 11000
Arm/Group Description	Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000
Measure Participants	56
Baseline	0.81 (0.20)
1 Year follow-up	0.87 (0.20)

8. Other Pre-specified Outcome

Title	Subject's Average White Blood Cell Count
Description	Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.
Time Frame	Baseline, 3-6 Months, and 1 through 5 Years

Outcome Measure Data

Analysis Population Description

This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.

Arm/Group Title	Aortic Bioprosthesis, Model 11000
Arm/Group Description	Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000
Measure Participants	133
Baseline	7.0 (1.7)
3-6 Months	7.5 (2.2)
1 Year	7.3 (1.8)
2 Year	7.2 (1.6)
3 Year	7.1 (1.8)
4 Year	7.2 (1.8)
5 Year	7.2 (1.9)

9. Other Pre-specified Outcome

Title	Subject's Average Red Blood Cells Count
Description	Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.
Time Frame	Baseline, 3-6 Months, and 1 through 5 Years

Outcome Measure Data

Analysis Population Description

This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.

Arm/Group Title	Aortic Bioprosthesis, Model 11000
Arm/Group Description	Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000
Measure Participants	133
Baseline	4.5 (0.5)
3-6 Months	4.7 (0.5)
1 Year	4.6 (0.4)
2 Year	4.6 (0.5)
3 Year	4.7 (0.5)
4 Year	4.6 (0.5)
5 Year	4.6 (0.5)

10. Other Pre-specified Outcome

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, 3-6 months, and 1 through 5 years

Outcome Measure Data

Analysis Population Description

This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.

Arm/Group Title	Aortic Bioprosthesis, Model 11000
Arm/Group Description	Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000
Measure Participants	133
Baseline	13.5 (1.5)
3-6 Months	13.3 (1.4)
1 Year	13.7 (1.4)
2 Years	13.8 (1.5)
3 Years	14.0 (1.3)
4 Years	13.9 (1.6)
5 Years	13.7 (1.5)

11. Other Pre-specified Outcome

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 fluid component(plasma) in the blood.
Time Frame	Baseline, 3-6 Months, and 1 through 5 Years

Outcome Measure Data

Analysis Population Description

This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.

Arm/Group Title	Aortic Bioprosthesis, Model 11000
Arm/Group Description	Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000
Measure Participants	133
Baseline	40.1 (4.2)
3-6 Months	40.5 (3.8)
1 Year	40.7 (3.5)
2 Years	41.1 (3.7)
3 Years	41.9 (3.6)
4 Years	41.9 (7.0)
5 Years	41.4 (4.0)

12. Other Pre-specified Outcome

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, 3-6 Months, and 1 through 5 Years

Outcome Measure Data

Analysis Population Description

This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.

Arm/Group Title	Aortic Bioprosthesis, Model 11000
Arm/Group Description	Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000
Measure Participants	133
Baseline	196.0 (48.3)
3-6 Months	203.1 (55.9)
1 Year	196.6 (49.8)
2 Years	195.8 (47.1)
3 Years	188.7 (45.4)
4 Years	194.4 (54.8)
5 Years	206.6 (57.7)

13. Other Pre-specified Outcome

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 liquid part of the blood (the serum).
Time Frame	Baseline, 3-6 Months, and 1 through 5 Years

Outcome Measure Data

Analysis Population Description

This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.

Arm/Group Title	Aortic Bioprosthesis, Model 11000
Arm/Group Description	Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000
Measure Participants	133
Baseline	12.9 (13.9)
3-6 Years	12.1 (8.1)
1 Year	14.2 (24.6)
2 Years	18.6 (27.7)
3 Years	19.3 (25.7)
4 Years	20.1 (26.6)
5 Years	28.1 (38.5)

14. Other Pre-specified Outcome

Title	Subject's Average Serum Creatinine
Description	Laboratory Analysis of Serum Creatinine on blood drawn from subjects. Creatinine blood test is a test that measures kidney function.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.

Arm/Group Title	Aortic Bioprosthesis, Model 11000
Arm/Group Description	Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000
Measure Participants	53
Mean (Standard Deviation) [micromol/l]	84.0 (17.4)

15. Other Pre-specified Outcome

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 liquid portion (plasma) of the blood to clot.
Time Frame	Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years

Outcome Measure Data

Analysis Population Description

This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.

Arm/Group Title	Aortic Bioprosthesis, Model 11000
Arm/Group Description	Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000
Measure Participants	133
Baseline	1.0 (0.1)
Discharge	1.9 (1.0)
3-6 Months	1.9 (0.8)
1 Year	1.2 (0.5)
3 Years	1.2 (0.6)
5 Years	1.2 (0.6)

16. Other Pre-specified Outcome

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, 3-6 Months, 1 Year, 3 Years, and 5 Years

Outcome Measure Data

Analysis Population Description

This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.

Arm/Group Title	Aortic Bioprosthesis, Model 11000
Arm/Group Description	Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000
Measure Participants	133
Baseline	30.0 (6.5)
Discharge	39.5 (10.5)
3-6 Months	35.1 (8.9)
1 Year	28.6 (5.2)
3 Years	29.9 (10.2)
5 Years	33.6 (10.2)

17. Other Pre-specified Outcome

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 liquid portion (plasma) of the blood to clot.
Time Frame	Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years

Outcome Measure Data

Analysis Population Description

This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.

Arm/Group Title	Aortic Bioprosthesis, Model 11000
Arm/Group Description	Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000
Measure Participants	133
Baseline	11.9 (1.9)
Discharge	21.5 (11.5)
3-6 Months	19.4 (9.1)
1 Year	14.0 (5.9)
3 Years	13.4 (5.3)
5 Years	12.5 (4.3)

Adverse Events

Time Frame	Events occurring from baseline through five years post implant
Arm/Group Title	Aortic Bioprosthesis, Model 11000
Arm/Group Description	Aortic valve replacement therapy Heart Valve Surgery: Implant of an aortic valve, Model 11000
All Cause Mortality
	Aortic Bioprosthesis, Model 11000
	Affected / at Risk (%)	# Events
Total	21/133 (15.8%)
Serious Adverse Events
	Aortic Bioprosthesis, Model 11000
	Affected / at Risk (%)	# Events
Total	74/133 (55.6%)
Blood and lymphatic system disorders
Anemia - non-bleeding related	1/133 (0.8%)	1
Bleeding event	12/133 (9%)	12
Cardiac disorders
Angina, stable	1/133 (0.8%)	1
Arrhythmia-AV block III	1/133 (0.8%)	1
Arrhythmia - AV block - 3rd degree	3/133 (2.3%)	3
Arrhythmia - bradycardia	1/133 (0.8%)	1
Arrhythmia - paroxysmal atrial fibrillation (PAF)	7/133 (5.3%)	9
Arrhythmia - persistent atrial fibrillation	3/133 (2.3%)	4
Arrhythmia - supraventricular tachycardia (SVT)	1/133 (0.8%)	1
Arrhythmia - tachy-bradycardia	1/133 (0.8%)	1
Arrhythmia - ventricular fibrillation	1/133 (0.8%)	1
Cardiac arrest	3/133 (2.3%)	3
Cardiac decompensation	4/133 (3%)	4
Cardiovascular - other	2/133 (1.5%)	2
Cardiovascular - other --> infection inflammation	1/133 (0.8%)	1
Endocarditis	1/133 (0.8%)	1
Heart failure - chronic (CHF)	2/133 (1.5%)	2
Hypertension - systemic	1/133 (0.8%)	1
Myocardial infarction	1/133 (0.8%)	1
Pericardial effusion	1/133 (0.8%)	1
Pericardial effusion - major	4/133 (3%)	4
Pericardial effusion - minor	1/133 (0.8%)	1
Pericardial tamponade - major	3/133 (2.3%)	3
Tachy-bradycardia	1/133 (0.8%)	1
Thromboembolism	5/133 (3.8%)	5
Valve thrombosis	1/133 (0.8%)	1
Endocrine disorders
Endocrine complications	1/133 (0.8%)	1
Eye disorders
Vision disorder	1/133 (0.8%)	1
Gastrointestinal disorders
Biliary (gallbladder)	3/133 (2.3%)	4
Gastrointestinal - other	5/133 (3.8%)	6
Pancreatic complication	1/133 (0.8%)	1
General disorders
Cancer - newly diagnosed	6/133 (4.5%)	6
Cancer - progression of underlying disease	2/133 (1.5%)	5
Nonspecific, unknown or other body system - other complication	4/133 (3%)	5
Sudden death	1/133 (0.8%)	1
Infections and infestations
Wound infection - other	1/133 (0.8%)	1
Musculoskeletal and connective tissue disorders
Bone fracture/break	3/133 (2.3%)	3
Muscular skeletal / dermatologic - other	5/133 (3.8%)	6
Sternal wound/thoracic infection	4/133 (3%)	4
Psychiatric disorders
Transient psychotic syndrome	1/133 (0.8%)	1
Renal and urinary disorders
Genitourinary - other	2/133 (1.5%)	3
Renal - other	3/133 (2.3%)	3
Renal dysfunction	1/133 (0.8%)	1
Renal failure - acute	2/133 (1.5%)	2
Renal failure - chronic	1/133 (0.8%)	1
Respiratory, thoracic and mediastinal disorders
Pleural effusion - bilateral	1/133 (0.8%)	1
Pleural effusion - left	3/133 (2.3%)	3
Pleural effusion - right	1/133 (0.8%)	1
Pneumothorax	1/133 (0.8%)	1
Pulmonary/respiratory - other	1/133 (0.8%)	1
Respiratory dysfunction/insufficiency	2/133 (1.5%)	2
Respiratory failure - pneumonia	2/133 (1.5%)	2
Respiratory infection - pneumonia	2/133 (1.5%)	2
Respiratory infection - upper	3/133 (2.3%)	3
Vascular disorders
Vascular - other	3/133 (2.3%)	3
Other (Not Including Serious) Adverse Events
	Aortic Bioprosthesis, Model 11000
	Affected / at Risk (%)	# Events
Total	41/133 (30.8%)
Blood and lymphatic system disorders
Bleeding event	1/133 (0.8%)	1
Cardiac disorders
Arrhythmia - AV block - 1st degree	1/133 (0.8%)	1
Arrhythmia - paroxysmal atrial fibrillation (PAF)	18/133 (13.5%)	18
Arrhythmia - paroxysmal atrial tachycardia (PAT)	1/133 (0.8%)	1
Arrhythmia - permanent atrial fibrillation	1/133 (0.8%)	1
Arrhythmia - persistent atrial fibrillation	4/133 (3%)	4
Arrhythmia - tachy-bradycardia	1/133 (0.8%)	1
Cardiovascular - other	1/133 (0.8%)	1
Non structural valve dysfunction	1/133 (0.8%)	1
Pericardial effusion - minor	1/133 (0.8%)	1
Stenosis - tricuspid - moderate	1/133 (0.8%)	1
Eye disorders
Vision disorder	4/133 (3%)	4
General disorders
Nonspecific, unknown or other body system - other complication	1/133 (0.8%)	1
Psychiatric disorders
Transient psychotic syndrome	3/133 (2.3%)	3
Renal and urinary disorders
Renal dysfunction	2/133 (1.5%)	2
Respiratory, thoracic and mediastinal disorders
Pleural effusion - right	1/133 (0.8%)	1
Pneumothorax	3/133 (2.3%)	3
Respiratory infection - upper	1/133 (0.8%)	1

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.