Trial Outcomes & Findings for Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000 (NCT NCT01651052)
NCT ID: NCT01651052
Last Updated: 2019-07-26
Results Overview
Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
133 participants
Primary outcome timeframe
Events occurring within 30 days of procedure
Results posted on
2019-07-26
Participant Flow
133 Subjects were enrolled and implanted with the study valve, for which data is available.
Participant milestones
| Measure |
Aortic Bioprosthesis, Model 11000
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Overall Study
STARTED
|
133
|
|
Overall Study
Study Valve Group
|
133
|
|
Overall Study
COMPLETED
|
107
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
Aortic Bioprosthesis, Model 11000
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Overall Study
Death
|
21
|
|
Overall Study
Explant
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
Baseline characteristics by cohort
| Measure |
Aortic Bioprosthesis, Model 11000
n=133 Participants
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Age, Continuous
|
65.3 Years
STANDARD_DEVIATION 13.5 • n=93 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
113 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=93 Participants
|
|
Region of Enrollment
Poland
|
133 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Events occurring within 30 days of procedureNumber of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100
Outcome measures
| Measure |
Aortic Bioprosthesis, Model 11000
n=133 Participants
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
All Cause Mortality
|
2.3 percentage
|
|
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
Trial valve-related Mortality
|
0.8 percentage
|
|
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
Study Valve Related Reoperation
|
0.0 percentage
|
|
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
Explant
|
0.0 percentage
|
|
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
Thromboembolism
|
2.3 percentage
|
|
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
Valve Thrombosis
|
0.0 percentage
|
|
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
Bleeding Event
|
8.3 percentage
|
|
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
Major Bleeding Event
|
6.8 percentage
|
|
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
Paravalvular Leak (PVL)
|
0.8 percentage
|
|
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
Major Paravalvular Leak
|
0.0 percentage
|
|
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
Endocarditis
|
0.0 percentage
|
|
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
Hemolysis
|
0.0 percentage
|
|
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
Nonstructural Valve Dysfunction (Not PVL)
|
0.0 percentage
|
|
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
Structural Valve Deterioration
|
0.0 percentage
|
PRIMARY outcome
Timeframe: Events occurring >= 31 days and up through 5 years post-implantNumber 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).
Outcome measures
| Measure |
Aortic Bioprosthesis, Model 11000
n=133 Participants
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
All Cause Mortality
|
3.2 Percentage of events/late patient years
|
|
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Trial valve-related mortality
|
0.7 Percentage of events/late patient years
|
|
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Study Valve Related Reoperation
|
0.2 Percentage of events/late patient years
|
|
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Explant
|
0.2 Percentage of events/late patient years
|
|
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Thromboembolism
|
0.4 Percentage of events/late patient years
|
|
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Valve Thrombosis
|
0.2 Percentage of events/late patient years
|
|
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Bleeding Event
|
0.4 Percentage of events/late patient years
|
|
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Major Bleeding Event
|
0.4 Percentage of events/late patient years
|
|
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Paravalvular Leak (PVL)
|
0.0 Percentage of events/late patient years
|
|
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Major Paravalvular Leak
|
0.0 Percentage of events/late patient years
|
|
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Endocarditis
|
0.2 Percentage of events/late patient years
|
|
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Hemolysis
|
0.0 Percentage of events/late patient years
|
|
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Nonstructural Valve Dysfunction (Not PVL)
|
0.2 Percentage of events/late patient years
|
|
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Structural Valve Deterioration
|
0.0 Percentage of events/late patient years
|
SECONDARY outcome
Timeframe: Baseline through 5-Year (at each scheduled follow-up visit)Population: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
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.
Outcome measures
| Measure |
Aortic Bioprosthesis, Model 11000
n=133 Participants
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Subject's Average Mean Gradient Measurements
Baseline
|
49.4 mmHg
Standard Deviation 21.7
|
|
Subject's Average Mean Gradient Measurements
Discharge
|
12.3 mmHg
Standard Deviation 5.3
|
|
Subject's Average Mean Gradient Measurements
3-6 months
|
12.2 mmHg
Standard Deviation 5.9
|
|
Subject's Average Mean Gradient Measurements
1 year
|
13.9 mmHg
Standard Deviation 6.1
|
|
Subject's Average Mean Gradient Measurements
2 year
|
13.8 mmHg
Standard Deviation 6.4
|
|
Subject's Average Mean Gradient Measurements
3 year
|
14.3 mmHg
Standard Deviation 6.1
|
|
Subject's Average Mean Gradient Measurements
4 year
|
15.0 mmHg
Standard Deviation 7.2
|
|
Subject's Average Mean Gradient Measurements
5 year
|
14.8 mmHg
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Baseline through 5-Year (at each scheduled follow-up visit)Population: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
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.
Outcome measures
| Measure |
Aortic Bioprosthesis, Model 11000
n=133 Participants
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Subject's Average Effective Orifice Area Measurements
Baseline
|
1.0 Centimeters squared
Standard Deviation 0.8
|
|
Subject's Average Effective Orifice Area Measurements
Discharge
|
2.0 Centimeters squared
Standard Deviation 0.6
|
|
Subject's Average Effective Orifice Area Measurements
3-6 Month
|
1.8 Centimeters squared
Standard Deviation 0.5
|
|
Subject's Average Effective Orifice Area Measurements
1 Year
|
1.8 Centimeters squared
Standard Deviation 0.6
|
|
Subject's Average Effective Orifice Area Measurements
2 Year
|
1.6 Centimeters squared
Standard Deviation 0.5
|
|
Subject's Average Effective Orifice Area Measurements
3 Year
|
1.5 Centimeters squared
Standard Deviation 0.5
|
|
Subject's Average Effective Orifice Area Measurements
4 Year
|
1.5 Centimeters squared
Standard Deviation 0.4
|
|
Subject's Average Effective Orifice Area Measurements
5 Year
|
1.4 Centimeters squared
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 3-6 Months and 1 through 5 Years compared to baselinePopulation: This outcome is reported for subjects who received the Model 11000 surgical aortic heart valve where data is available.
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.
Outcome measures
| Measure |
Aortic Bioprosthesis, Model 11000
n=133 Participants
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Improve at 3-6 Months
|
89 Participants
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Same at 3-6 Months
|
36 Participants
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Worse at 3-6 months
|
3 Participants
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Improve at 1 Year
|
68 Participants
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Same at 1 Year
|
48 Participants
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Worse at 1 Year
|
6 Participants
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Improve at 2 Years
|
68 Participants
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Same at 2 Years
|
34 Participants
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Worse at 2 Years
|
9 Participants
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Improve at 3 Years
|
59 Participants
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Same at 3 Years
|
41 Participants
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Worse at 3 Years
|
5 Participants
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Improve at 4 Years
|
55 Participants
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Same at 4 Years
|
40 Participants
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Worse at 4 Years
|
6 Participants
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Improve at 5 Years
|
50 Participants
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Same at 5 Years
|
33 Participants
|
|
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Worse at 5 Years
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline and one year follow-upPopulation: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
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.
Outcome measures
| Measure |
Aortic Bioprosthesis, Model 11000
n=56 Participants
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey
Physical Health - Baseline
|
42.5 units on a scale
Standard Deviation 10.2
|
|
Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey
Physical Health - 1 Year follow-up
|
49 units on a scale
Standard Deviation 7.4
|
|
Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey
Mental Health - Baseline
|
50.2 units on a scale
Standard Deviation 8.6
|
|
Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey
Mental Health - 1 Year follow-up
|
51.2 units on a scale
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Baseline and 1 YearPopulation: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
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.
Outcome measures
| Measure |
Aortic Bioprosthesis, Model 11000
n=56 Participants
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
Baseline
|
0.81 units on a scale
Standard Deviation 0.20
|
|
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
1 Year follow-up
|
0.87 units on a scale
Standard Deviation 0.20
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3-6 Months, and 1 through 5 YearsPopulation: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.
Outcome measures
| Measure |
Aortic Bioprosthesis, Model 11000
n=133 Participants
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Subject's Average White Blood Cell Count
Baseline
|
7.0 10^3 cells/microliters
Standard Deviation 1.7
|
|
Subject's Average White Blood Cell Count
3-6 Months
|
7.5 10^3 cells/microliters
Standard Deviation 2.2
|
|
Subject's Average White Blood Cell Count
1 Year
|
7.3 10^3 cells/microliters
Standard Deviation 1.8
|
|
Subject's Average White Blood Cell Count
2 Year
|
7.2 10^3 cells/microliters
Standard Deviation 1.6
|
|
Subject's Average White Blood Cell Count
3 Year
|
7.1 10^3 cells/microliters
Standard Deviation 1.8
|
|
Subject's Average White Blood Cell Count
4 Year
|
7.2 10^3 cells/microliters
Standard Deviation 1.8
|
|
Subject's Average White Blood Cell Count
5 Year
|
7.2 10^3 cells/microliters
Standard Deviation 1.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3-6 Months, and 1 through 5 YearsPopulation: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.
Outcome measures
| Measure |
Aortic Bioprosthesis, Model 11000
n=133 Participants
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Subject's Average Red Blood Cells Count
Baseline
|
4.5 10^6 cells/microliters
Standard Deviation 0.5
|
|
Subject's Average Red Blood Cells Count
3-6 Months
|
4.7 10^6 cells/microliters
Standard Deviation 0.5
|
|
Subject's Average Red Blood Cells Count
1 Year
|
4.6 10^6 cells/microliters
Standard Deviation 0.4
|
|
Subject's Average Red Blood Cells Count
2 Year
|
4.6 10^6 cells/microliters
Standard Deviation 0.5
|
|
Subject's Average Red Blood Cells Count
3 Year
|
4.7 10^6 cells/microliters
Standard Deviation 0.5
|
|
Subject's Average Red Blood Cells Count
4 Year
|
4.6 10^6 cells/microliters
Standard Deviation 0.5
|
|
Subject's Average Red Blood Cells Count
5 Year
|
4.6 10^6 cells/microliters
Standard Deviation 0.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3-6 months, and 1 through 5 yearsPopulation: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.
Outcome measures
| Measure |
Aortic Bioprosthesis, Model 11000
n=133 Participants
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Subject's Average Hemoglobin Count
Baseline
|
13.5 g/dl
Standard Deviation 1.5
|
|
Subject's Average Hemoglobin Count
3-6 Months
|
13.3 g/dl
Standard Deviation 1.4
|
|
Subject's Average Hemoglobin Count
1 Year
|
13.7 g/dl
Standard Deviation 1.4
|
|
Subject's Average Hemoglobin Count
2 Years
|
13.8 g/dl
Standard Deviation 1.5
|
|
Subject's Average Hemoglobin Count
3 Years
|
14.0 g/dl
Standard Deviation 1.3
|
|
Subject's Average Hemoglobin Count
4 Years
|
13.9 g/dl
Standard Deviation 1.6
|
|
Subject's Average Hemoglobin Count
5 Years
|
13.7 g/dl
Standard Deviation 1.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3-6 Months, and 1 through 5 YearsPopulation: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
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.
Outcome measures
| Measure |
Aortic Bioprosthesis, Model 11000
n=133 Participants
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Subject's Average Hematocrit Percentage
Baseline
|
40.1 percentage of red blood cells
Standard Deviation 4.2
|
|
Subject's Average Hematocrit Percentage
3-6 Months
|
40.5 percentage of red blood cells
Standard Deviation 3.8
|
|
Subject's Average Hematocrit Percentage
1 Year
|
40.7 percentage of red blood cells
Standard Deviation 3.5
|
|
Subject's Average Hematocrit Percentage
2 Years
|
41.1 percentage of red blood cells
Standard Deviation 3.7
|
|
Subject's Average Hematocrit Percentage
3 Years
|
41.9 percentage of red blood cells
Standard Deviation 3.6
|
|
Subject's Average Hematocrit Percentage
4 Years
|
41.9 percentage of red blood cells
Standard Deviation 7.0
|
|
Subject's Average Hematocrit Percentage
5 Years
|
41.4 percentage of red blood cells
Standard Deviation 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3-6 Months, and 1 through 5 YearsPopulation: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.
Outcome measures
| Measure |
Aortic Bioprosthesis, Model 11000
n=133 Participants
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Subject's Average Platelet Count
Baseline
|
196.0 10^3 platelets per microliter
Standard Deviation 48.3
|
|
Subject's Average Platelet Count
3-6 Months
|
203.1 10^3 platelets per microliter
Standard Deviation 55.9
|
|
Subject's Average Platelet Count
1 Year
|
196.6 10^3 platelets per microliter
Standard Deviation 49.8
|
|
Subject's Average Platelet Count
2 Years
|
195.8 10^3 platelets per microliter
Standard Deviation 47.1
|
|
Subject's Average Platelet Count
3 Years
|
188.7 10^3 platelets per microliter
Standard Deviation 45.4
|
|
Subject's Average Platelet Count
4 Years
|
194.4 10^3 platelets per microliter
Standard Deviation 54.8
|
|
Subject's Average Platelet Count
5 Years
|
206.6 10^3 platelets per microliter
Standard Deviation 57.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3-6 Months, and 1 through 5 YearsPopulation: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
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).
Outcome measures
| Measure |
Aortic Bioprosthesis, Model 11000
n=133 Participants
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Subject's Average Plasma Free Hemoglobin
Baseline
|
12.9 mg/dl
Standard Deviation 13.9
|
|
Subject's Average Plasma Free Hemoglobin
3-6 Years
|
12.1 mg/dl
Standard Deviation 8.1
|
|
Subject's Average Plasma Free Hemoglobin
1 Year
|
14.2 mg/dl
Standard Deviation 24.6
|
|
Subject's Average Plasma Free Hemoglobin
2 Years
|
18.6 mg/dl
Standard Deviation 27.7
|
|
Subject's Average Plasma Free Hemoglobin
3 Years
|
19.3 mg/dl
Standard Deviation 25.7
|
|
Subject's Average Plasma Free Hemoglobin
4 Years
|
20.1 mg/dl
Standard Deviation 26.6
|
|
Subject's Average Plasma Free Hemoglobin
5 Years
|
28.1 mg/dl
Standard Deviation 38.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
Laboratory Analysis of Serum Creatinine on blood drawn from subjects. Creatinine blood test is a test that measures kidney function.
Outcome measures
| Measure |
Aortic Bioprosthesis, Model 11000
n=53 Participants
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Subject's Average Serum Creatinine
|
84.0 micromol/l
Standard Deviation 17.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 YearsPopulation: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
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.
Outcome measures
| Measure |
Aortic Bioprosthesis, Model 11000
n=133 Participants
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Subject's Average International Normalized Ratio
Baseline
|
1.0 Ratio
Standard Deviation 0.1
|
|
Subject's Average International Normalized Ratio
Discharge
|
1.9 Ratio
Standard Deviation 1.0
|
|
Subject's Average International Normalized Ratio
3-6 Months
|
1.9 Ratio
Standard Deviation 0.8
|
|
Subject's Average International Normalized Ratio
1 Year
|
1.2 Ratio
Standard Deviation 0.5
|
|
Subject's Average International Normalized Ratio
3 Years
|
1.2 Ratio
Standard Deviation 0.6
|
|
Subject's Average International Normalized Ratio
5 Years
|
1.2 Ratio
Standard Deviation 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 YearsPopulation: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
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.
Outcome measures
| Measure |
Aortic Bioprosthesis, Model 11000
n=133 Participants
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Subject's Average Partial Thromboplastin Time
Baseline
|
30.0 Seconds
Standard Deviation 6.5
|
|
Subject's Average Partial Thromboplastin Time
Discharge
|
39.5 Seconds
Standard Deviation 10.5
|
|
Subject's Average Partial Thromboplastin Time
3-6 Months
|
35.1 Seconds
Standard Deviation 8.9
|
|
Subject's Average Partial Thromboplastin Time
1 Year
|
28.6 Seconds
Standard Deviation 5.2
|
|
Subject's Average Partial Thromboplastin Time
3 Years
|
29.9 Seconds
Standard Deviation 10.2
|
|
Subject's Average Partial Thromboplastin Time
5 Years
|
33.6 Seconds
Standard Deviation 10.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 YearsPopulation: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
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.
Outcome measures
| Measure |
Aortic Bioprosthesis, Model 11000
n=133 Participants
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Subject's Average Prothrombin Time
Baseline
|
11.9 Seconds
Standard Deviation 1.9
|
|
Subject's Average Prothrombin Time
Discharge
|
21.5 Seconds
Standard Deviation 11.5
|
|
Subject's Average Prothrombin Time
3-6 Months
|
19.4 Seconds
Standard Deviation 9.1
|
|
Subject's Average Prothrombin Time
1 Year
|
14.0 Seconds
Standard Deviation 5.9
|
|
Subject's Average Prothrombin Time
3 Years
|
13.4 Seconds
Standard Deviation 5.3
|
|
Subject's Average Prothrombin Time
5 Years
|
12.5 Seconds
Standard Deviation 4.3
|
Adverse Events
Aortic Bioprosthesis, Model 11000
Serious events: 74 serious events
Other events: 41 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Aortic Bioprosthesis, Model 11000
n=133 participants at risk
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Blood and lymphatic system disorders
Anemia - non-bleeding related
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Angina, stable
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Arrhythmia-AV block III
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Arrhythmia - AV block - 3rd degree
|
2.3%
3/133 • Number of events 3 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Arrhythmia - bradycardia
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Arrhythmia - paroxysmal atrial fibrillation (PAF)
|
5.3%
7/133 • Number of events 9 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Arrhythmia - persistent atrial fibrillation
|
2.3%
3/133 • Number of events 4 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Arrhythmia - supraventricular tachycardia (SVT)
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Arrhythmia - tachy-bradycardia
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Arrhythmia - ventricular fibrillation
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Gastrointestinal disorders
Biliary (gallbladder)
|
2.3%
3/133 • Number of events 4 • Events occurring from baseline through five years post implant
|
|
Blood and lymphatic system disorders
Bleeding event
|
9.0%
12/133 • Number of events 12 • Events occurring from baseline through five years post implant
|
|
Musculoskeletal and connective tissue disorders
Bone fracture/break
|
2.3%
3/133 • Number of events 3 • Events occurring from baseline through five years post implant
|
|
General disorders
Cancer - newly diagnosed
|
4.5%
6/133 • Number of events 6 • Events occurring from baseline through five years post implant
|
|
General disorders
Cancer - progression of underlying disease
|
1.5%
2/133 • Number of events 5 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Cardiac arrest
|
2.3%
3/133 • Number of events 3 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Cardiac decompensation
|
3.0%
4/133 • Number of events 4 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Cardiovascular - other
|
1.5%
2/133 • Number of events 2 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Cardiovascular - other --> infection inflammation
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Endocarditis
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Endocrine disorders
Endocrine complications
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Gastrointestinal disorders
Gastrointestinal - other
|
3.8%
5/133 • Number of events 6 • Events occurring from baseline through five years post implant
|
|
Renal and urinary disorders
Genitourinary - other
|
1.5%
2/133 • Number of events 3 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Heart failure - chronic (CHF)
|
1.5%
2/133 • Number of events 2 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Hypertension - systemic
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Musculoskeletal and connective tissue disorders
Muscular skeletal / dermatologic - other
|
3.8%
5/133 • Number of events 6 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Myocardial infarction
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
General disorders
Nonspecific, unknown or other body system - other complication
|
3.0%
4/133 • Number of events 5 • Events occurring from baseline through five years post implant
|
|
Gastrointestinal disorders
Pancreatic complication
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Pericardial effusion
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Pericardial effusion - major
|
3.0%
4/133 • Number of events 4 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Pericardial effusion - minor
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Pericardial tamponade - major
|
2.3%
3/133 • Number of events 3 • Events occurring from baseline through five years post implant
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion - bilateral
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion - left
|
2.3%
3/133 • Number of events 3 • Events occurring from baseline through five years post implant
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion - right
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/respiratory - other
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Renal and urinary disorders
Renal - other
|
2.3%
3/133 • Number of events 3 • Events occurring from baseline through five years post implant
|
|
Renal and urinary disorders
Renal dysfunction
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Renal and urinary disorders
Renal failure - acute
|
1.5%
2/133 • Number of events 2 • Events occurring from baseline through five years post implant
|
|
Renal and urinary disorders
Renal failure - chronic
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory dysfunction/insufficiency
|
1.5%
2/133 • Number of events 2 • Events occurring from baseline through five years post implant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure - pneumonia
|
1.5%
2/133 • Number of events 2 • Events occurring from baseline through five years post implant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infection - pneumonia
|
1.5%
2/133 • Number of events 2 • Events occurring from baseline through five years post implant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infection - upper
|
2.3%
3/133 • Number of events 3 • Events occurring from baseline through five years post implant
|
|
Musculoskeletal and connective tissue disorders
Sternal wound/thoracic infection
|
3.0%
4/133 • Number of events 4 • Events occurring from baseline through five years post implant
|
|
General disorders
Sudden death
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Tachy-bradycardia
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Thromboembolism
|
3.8%
5/133 • Number of events 5 • Events occurring from baseline through five years post implant
|
|
Psychiatric disorders
Transient psychotic syndrome
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Valve thrombosis
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Vascular disorders
Vascular - other
|
2.3%
3/133 • Number of events 3 • Events occurring from baseline through five years post implant
|
|
Eye disorders
Vision disorder
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Infections and infestations
Wound infection - other
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
Other adverse events
| Measure |
Aortic Bioprosthesis, Model 11000
n=133 participants at risk
Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000
|
|---|---|
|
Cardiac disorders
Arrhythmia - AV block - 1st degree
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Arrhythmia - paroxysmal atrial fibrillation (PAF)
|
13.5%
18/133 • Number of events 18 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Arrhythmia - paroxysmal atrial tachycardia (PAT)
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Arrhythmia - permanent atrial fibrillation
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Arrhythmia - persistent atrial fibrillation
|
3.0%
4/133 • Number of events 4 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Arrhythmia - tachy-bradycardia
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Blood and lymphatic system disorders
Bleeding event
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Cardiovascular - other
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Non structural valve dysfunction
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
General disorders
Nonspecific, unknown or other body system - other complication
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Pericardial effusion - minor
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion - right
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.3%
3/133 • Number of events 3 • Events occurring from baseline through five years post implant
|
|
Renal and urinary disorders
Renal dysfunction
|
1.5%
2/133 • Number of events 2 • Events occurring from baseline through five years post implant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infection - upper
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Cardiac disorders
Stenosis - tricuspid - moderate
|
0.75%
1/133 • Number of events 1 • Events occurring from baseline through five years post implant
|
|
Psychiatric disorders
Transient psychotic syndrome
|
2.3%
3/133 • Number of events 3 • Events occurring from baseline through five years post implant
|
|
Eye disorders
Vision disorder
|
3.0%
4/133 • Number of events 4 • Events occurring from baseline through five years post implant
|
Additional Information
Mary Edwards, VP Clinical and Regulatory Affairs, Surgical Structural Heart
Edwards Lifesciences, LLC
Phone: 949-250-2500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER