Aortic Valve Disorder, Aortic Valve Insufficiency, Aortic Valve Stenosis, Coronary Artery Disease, Heart Failure
Conditions
Keywords
Aortic valve replacement/regurgitation
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.
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.
Interventions
PROCEDUREHeart Valve Surgery
Implant of an aortic valve, Model 11000
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
Countries
Poland
Participant flow
Pre-assignment details
133 Subjects were enrolled and implanted with the study valve, for which data is available.
Participants by arm
| Arm | Count |
|---|---|
| Aortic Bioprosthesis, Model 11000 Aortic valve replacement therapy
Heart Valve Surgery: Implant of an aortic valve, Model 11000 | 133 |
| Total | 133 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 21 |
| Overall Study | Explant | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Aortic Bioprosthesis, Model 11000 |
|---|---|
| Age, Continuous | 65.3 Years STANDARD_DEVIATION 13.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 113 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 20 Participants |
| Region of Enrollment Poland | 133 Participants |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 21 / 133 |
| other Total, other adverse events | 41 / 133 |
| serious Total, serious adverse events | 74 / 133 |
Outcome results
Primary
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aortic Bioprosthesis, Model 11000 | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Study Valve Related Reoperation | 0.0 percentage |
| Aortic Bioprosthesis, Model 11000 | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Explant | 0.0 percentage |
| Aortic Bioprosthesis, Model 11000 | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Nonstructural Valve Dysfunction (Not PVL) | 0.0 percentage |
| Aortic Bioprosthesis, Model 11000 | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | All Cause Mortality | 2.3 percentage |
| Aortic Bioprosthesis, Model 11000 | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Trial valve-related Mortality | 0.8 percentage |
| Aortic Bioprosthesis, Model 11000 | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Thromboembolism | 2.3 percentage |
| Aortic Bioprosthesis, Model 11000 | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Valve Thrombosis | 0.0 percentage |
| Aortic Bioprosthesis, Model 11000 | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Bleeding Event | 8.3 percentage |
| Aortic Bioprosthesis, Model 11000 | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Major Bleeding Event | 6.8 percentage |
| Aortic Bioprosthesis, Model 11000 | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Paravalvular Leak (PVL) | 0.8 percentage |
| Aortic Bioprosthesis, Model 11000 | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Major Paravalvular Leak | 0.0 percentage |
| Aortic Bioprosthesis, Model 11000 | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Endocarditis | 0.0 percentage |
| Aortic Bioprosthesis, Model 11000 | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Hemolysis | 0.0 percentage |
| Aortic Bioprosthesis, Model 11000 | Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) | Structural Valve Deterioration | 0.0 percentage |
Primary
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aortic Bioprosthesis, Model 11000 | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Explant | 0.2 Percentage of events/late patient years |
| Aortic Bioprosthesis, Model 11000 | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Thromboembolism | 0.4 Percentage of events/late patient years |
| Aortic Bioprosthesis, 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 |
| Aortic Bioprosthesis, Model 11000 | 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 |
| Aortic Bioprosthesis, Model 11000 | 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 |
| Aortic Bioprosthesis, Model 11000 | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Valve Thrombosis | 0.2 Percentage of events/late patient years |
| Aortic Bioprosthesis, Model 11000 | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Bleeding Event | 0.4 Percentage of events/late patient years |
| Aortic Bioprosthesis, Model 11000 | 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 |
| Aortic Bioprosthesis, Model 11000 | 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 |
| Aortic Bioprosthesis, Model 11000 | 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 |
| Aortic Bioprosthesis, Model 11000 | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Endocarditis | 0.2 Percentage of events/late patient years |
| Aortic Bioprosthesis, Model 11000 | Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) | Hemolysis | 0.0 Percentage of events/late patient years |
| Aortic Bioprosthesis, Model 11000 | 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 |
| Aortic Bioprosthesis, Model 11000 | 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
Subject's Average Effective Orifice Area Measurements
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)
Population: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aortic Bioprosthesis, Model 11000 | Subject's Average Effective Orifice Area Measurements | 3 Year | 1.5 Centimeters squared | Standard Deviation 0.5 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Effective Orifice Area Measurements | 4 Year | 1.5 Centimeters squared | Standard Deviation 0.4 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Effective Orifice Area Measurements | Baseline | 1.0 Centimeters squared | Standard Deviation 0.8 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Effective Orifice Area Measurements | Discharge | 2.0 Centimeters squared | Standard Deviation 0.6 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Effective Orifice Area Measurements | 3-6 Month | 1.8 Centimeters squared | Standard Deviation 0.5 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Effective Orifice Area Measurements | 1 Year | 1.8 Centimeters squared | Standard Deviation 0.6 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Effective Orifice Area Measurements | 2 Year | 1.6 Centimeters squared | Standard Deviation 0.5 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Effective Orifice Area Measurements | 5 Year | 1.4 Centimeters squared | Standard Deviation 0.5 |
Secondary
Subject's Average Mean Gradient Measurements
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)
Population: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aortic Bioprosthesis, Model 11000 | Subject's Average Mean Gradient Measurements | Baseline | 49.4 mmHg | Standard Deviation 21.7 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Mean Gradient Measurements | Discharge | 12.3 mmHg | Standard Deviation 5.3 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Mean Gradient Measurements | 3-6 months | 12.2 mmHg | Standard Deviation 5.9 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Mean Gradient Measurements | 1 year | 13.9 mmHg | Standard Deviation 6.1 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Mean Gradient Measurements | 2 year | 13.8 mmHg | Standard Deviation 6.4 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Mean Gradient Measurements | 3 year | 14.3 mmHg | Standard Deviation 6.1 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Mean Gradient Measurements | 4 year | 15.0 mmHg | Standard Deviation 7.2 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Mean Gradient Measurements | 5 year | 14.8 mmHg | Standard Deviation 7.6 |
Secondary
Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey
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
Population: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aortic Bioprosthesis, 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 |
| Aortic Bioprosthesis, Model 11000 | 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 |
| Aortic Bioprosthesis, Model 11000 | 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 |
| Aortic Bioprosthesis, Model 11000 | 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
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
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
Population: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aortic Bioprosthesis, 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 0.2 |
| Aortic Bioprosthesis, Model 11000 | 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 0.2 |
Secondary
Subject's New York Heart Association (NYHA) Functional Class 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.
Time frame: 3-6 Months and 1 through 5 Years compared to baseline
Population: This outcome is reported for subjects who received the Model 11000 surgical aortic heart valve where data is available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aortic Bioprosthesis, Model 11000 | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline. | Improve at 1 Year | 68 Participants |
| Aortic Bioprosthesis, Model 11000 | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline. | Same at 1 Year | 48 Participants |
| Aortic Bioprosthesis, Model 11000 | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline. | Worse at 1 Year | 6 Participants |
| Aortic Bioprosthesis, Model 11000 | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline. | Worse at 4 Years | 6 Participants |
| Aortic Bioprosthesis, Model 11000 | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline. | Improve at 5 Years | 50 Participants |
| Aortic Bioprosthesis, Model 11000 | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline. | Same at 5 Years | 33 Participants |
| Aortic Bioprosthesis, Model 11000 | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline. | Worse at 5 Years | 8 Participants |
| Aortic Bioprosthesis, Model 11000 | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline. | Improve at 3-6 Months | 89 Participants |
| Aortic Bioprosthesis, Model 11000 | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline. | Same at 3-6 Months | 36 Participants |
| Aortic Bioprosthesis, Model 11000 | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline. | Worse at 3-6 months | 3 Participants |
| Aortic Bioprosthesis, Model 11000 | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline. | Improve at 2 Years | 68 Participants |
| Aortic Bioprosthesis, Model 11000 | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline. | Same at 2 Years | 34 Participants |
| Aortic Bioprosthesis, Model 11000 | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline. | Worse at 2 Years | 9 Participants |
| Aortic Bioprosthesis, Model 11000 | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline. | Improve at 3 Years | 59 Participants |
| Aortic Bioprosthesis, Model 11000 | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline. | Same at 3 Years | 41 Participants |
| Aortic Bioprosthesis, Model 11000 | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline. | Worse at 3 Years | 5 Participants |
| Aortic Bioprosthesis, Model 11000 | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline. | Improve at 4 Years | 55 Participants |
| Aortic Bioprosthesis, Model 11000 | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline. | Same at 4 Years | 40 Participants |
Other Pre-specified
Subject's Average Hematocrit Percentage
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
Population: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aortic Bioprosthesis, Model 11000 | Subject's Average Hematocrit Percentage | Baseline | 40.1 percentage of red blood cells | Standard Deviation 4.2 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Hematocrit Percentage | 3-6 Months | 40.5 percentage of red blood cells | Standard Deviation 3.8 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Hematocrit Percentage | 1 Year | 40.7 percentage of red blood cells | Standard Deviation 3.5 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Hematocrit Percentage | 2 Years | 41.1 percentage of red blood cells | Standard Deviation 3.7 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Hematocrit Percentage | 3 Years | 41.9 percentage of red blood cells | Standard Deviation 3.6 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Hematocrit Percentage | 4 Years | 41.9 percentage of red blood cells | Standard Deviation 7 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Hematocrit Percentage | 5 Years | 41.4 percentage of red blood cells | Standard Deviation 4 |
Other Pre-specified
Subject's Average Hemoglobin Count
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
Population: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aortic Bioprosthesis, Model 11000 | Subject's Average Hemoglobin Count | Baseline | 13.5 g/dl | Standard Deviation 1.5 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Hemoglobin Count | 3-6 Months | 13.3 g/dl | Standard Deviation 1.4 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Hemoglobin Count | 1 Year | 13.7 g/dl | Standard Deviation 1.4 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Hemoglobin Count | 2 Years | 13.8 g/dl | Standard Deviation 1.5 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Hemoglobin Count | 3 Years | 14.0 g/dl | Standard Deviation 1.3 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Hemoglobin Count | 4 Years | 13.9 g/dl | Standard Deviation 1.6 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Hemoglobin Count | 5 Years | 13.7 g/dl | Standard Deviation 1.5 |
Other Pre-specified
Subject's Average International Normalized Ratio
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
Population: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aortic Bioprosthesis, Model 11000 | Subject's Average International Normalized Ratio | Baseline | 1.0 Ratio | Standard Deviation 0.1 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average International Normalized Ratio | Discharge | 1.9 Ratio | Standard Deviation 1 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average International Normalized Ratio | 3-6 Months | 1.9 Ratio | Standard Deviation 0.8 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average International Normalized Ratio | 1 Year | 1.2 Ratio | Standard Deviation 0.5 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average International Normalized Ratio | 3 Years | 1.2 Ratio | Standard Deviation 0.6 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average International Normalized Ratio | 5 Years | 1.2 Ratio | Standard Deviation 0.6 |
Other Pre-specified
Subject's Average Partial Thromboplastin Time
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
Population: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aortic Bioprosthesis, Model 11000 | Subject's Average Partial Thromboplastin Time | Baseline | 30.0 Seconds | Standard Deviation 6.5 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Partial Thromboplastin Time | Discharge | 39.5 Seconds | Standard Deviation 10.5 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Partial Thromboplastin Time | 3-6 Months | 35.1 Seconds | Standard Deviation 8.9 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Partial Thromboplastin Time | 1 Year | 28.6 Seconds | Standard Deviation 5.2 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Partial Thromboplastin Time | 3 Years | 29.9 Seconds | Standard Deviation 10.2 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Partial Thromboplastin Time | 5 Years | 33.6 Seconds | Standard Deviation 10.2 |
Other Pre-specified
Subject's Average Plasma Free Hemoglobin
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
Population: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aortic Bioprosthesis, Model 11000 | Subject's Average Plasma Free Hemoglobin | 5 Years | 28.1 mg/dl | Standard Deviation 38.5 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Plasma Free Hemoglobin | Baseline | 12.9 mg/dl | Standard Deviation 13.9 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Plasma Free Hemoglobin | 3-6 Years | 12.1 mg/dl | Standard Deviation 8.1 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Plasma Free Hemoglobin | 1 Year | 14.2 mg/dl | Standard Deviation 24.6 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Plasma Free Hemoglobin | 2 Years | 18.6 mg/dl | Standard Deviation 27.7 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Plasma Free Hemoglobin | 3 Years | 19.3 mg/dl | Standard Deviation 25.7 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Plasma Free Hemoglobin | 4 Years | 20.1 mg/dl | Standard Deviation 26.6 |
Other Pre-specified
Subject's Average Platelet Count
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
Population: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aortic Bioprosthesis, Model 11000 | Subject's Average Platelet Count | Baseline | 196.0 10^3 platelets per microliter | Standard Deviation 48.3 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Platelet Count | 3-6 Months | 203.1 10^3 platelets per microliter | Standard Deviation 55.9 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Platelet Count | 1 Year | 196.6 10^3 platelets per microliter | Standard Deviation 49.8 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Platelet Count | 2 Years | 195.8 10^3 platelets per microliter | Standard Deviation 47.1 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Platelet Count | 3 Years | 188.7 10^3 platelets per microliter | Standard Deviation 45.4 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Platelet Count | 4 Years | 194.4 10^3 platelets per microliter | Standard Deviation 54.8 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Platelet Count | 5 Years | 206.6 10^3 platelets per microliter | Standard Deviation 57.7 |
Other Pre-specified
Subject's Average Prothrombin Time
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
Population: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aortic Bioprosthesis, Model 11000 | Subject's Average Prothrombin Time | Baseline | 11.9 Seconds | Standard Deviation 1.9 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Prothrombin Time | Discharge | 21.5 Seconds | Standard Deviation 11.5 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Prothrombin Time | 3-6 Months | 19.4 Seconds | Standard Deviation 9.1 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Prothrombin Time | 1 Year | 14.0 Seconds | Standard Deviation 5.9 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Prothrombin Time | 3 Years | 13.4 Seconds | Standard Deviation 5.3 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Prothrombin Time | 5 Years | 12.5 Seconds | Standard Deviation 4.3 |
Other Pre-specified
Subject's Average Red Blood Cells Count
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
Population: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aortic Bioprosthesis, Model 11000 | Subject's Average Red Blood Cells Count | Baseline | 4.5 10^6 cells/microliters | Standard Deviation 0.5 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Red Blood Cells Count | 3-6 Months | 4.7 10^6 cells/microliters | Standard Deviation 0.5 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Red Blood Cells Count | 1 Year | 4.6 10^6 cells/microliters | Standard Deviation 0.4 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Red Blood Cells Count | 2 Year | 4.6 10^6 cells/microliters | Standard Deviation 0.5 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Red Blood Cells Count | 3 Year | 4.7 10^6 cells/microliters | Standard Deviation 0.5 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Red Blood Cells Count | 4 Year | 4.6 10^6 cells/microliters | Standard Deviation 0.5 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average Red Blood Cells Count | 5 Year | 4.6 10^6 cells/microliters | Standard Deviation 0.5 |
Other Pre-specified
Subject's Average Serum Creatinine
Laboratory Analysis of Serum Creatinine on blood drawn from subjects. Creatinine blood test is a test that measures kidney function.
Time frame: Baseline
Population: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aortic Bioprosthesis, Model 11000 | Subject's Average Serum Creatinine | 84.0 micromol/l | Standard Deviation 17.4 |
Other Pre-specified
Subject's Average White Blood Cell Count
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
Population: This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aortic Bioprosthesis, Model 11000 | Subject's Average White Blood Cell Count | Baseline | 7.0 10^3 cells/microliters | Standard Deviation 1.7 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average White Blood Cell Count | 3-6 Months | 7.5 10^3 cells/microliters | Standard Deviation 2.2 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average White Blood Cell Count | 1 Year | 7.3 10^3 cells/microliters | Standard Deviation 1.8 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average White Blood Cell Count | 2 Year | 7.2 10^3 cells/microliters | Standard Deviation 1.6 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average White Blood Cell Count | 3 Year | 7.1 10^3 cells/microliters | Standard Deviation 1.8 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average White Blood Cell Count | 4 Year | 7.2 10^3 cells/microliters | Standard Deviation 1.8 |
| Aortic Bioprosthesis, Model 11000 | Subject's Average White Blood Cell Count | 5 Year | 7.2 10^3 cells/microliters | Standard Deviation 1.9 |