Aortic Valve Disorder, Aortic Valve Insufficiency, Aortic Valve Stenosis, Coronary Artery Disease, Heart Failure
Conditions
Keywords
PERIMOUNT, Aortic valve replacement/regurgitation
Brief summary
The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.
Detailed description
This is a prospective, single-arm, multi-center, interventional study to be conducted in the US and outside the US (OUS). This study will enroll a minimum of 225 patients implanted with the study valve in order to achieve 101 aortic valve replacement subjects each followed for a minimum of 8 years. The study will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged or malfunctioning natural or prosthetic aortic valve. Patients will be followed and assessed after implant at discharge, 6 months, one year, and annually for a minimum of 8 years.
Interventions
DEVICEImplantation of CEP Magna Ease Model 3300TFX
Heart Valve Surgery
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
1. The patient requires, as indicated in the preoperative evaluation, a replacement aortic valve. 2. The patient is an average or better operative risk. 3. The patient is geographically stable and agrees to attend follow-up assessments at the hospital of surgical services for at least 8 years. 4. The patient is 18 years or older. 5. The patient has signed and dated the subject informed consent form prior to surgery.
Exclusion criteria
1. The patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year. 2. The patient presents with active endocarditis within the last 3 months. 3. The patient has an abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidism). 4. The patient has an aneurismal aortic degenerative condition (e.g., cystic medial necrosis, Marfan's syndrome). 5. The patient is pregnant or lactating. 6. The patient is an intravenous drug abuser. 7. The patient is currently a prison inmate. 8. The patient is currently participating in a study of an investigational drug or device. 9. The patient requires replacement of a native or prosthetic mitral, tricuspid or pulmonic valve. 10. The patient requires a repair of the mitral or tricuspid valve with the use of an annuloplasty device. 11. The patient was previously enrolled in the study. 12. The patient had a prior mitral, tricuspid or pulmonic valve surgery, which included implantation of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject's Percentage of Long Term Safety Performance | 31 days through 8 years post-implant | Long term safety performance will be evaluated by comparing the linearized yearly rates to the objective performance criteria (OPC) referenced in the Food and Drug Administration (FDA) 1994 Draft Heart Valve Guidance. Expressed as the Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event). |
| Number of Subject's in NYHA Functional Class I or II at 8 Year Post-Implant | 8 years post-implant | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). |
| Subject's New York Heart Association (NYHA) Functional Class at 8 Years Post-Implant Compared to Baseline | 8 Years post-implant | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject's Average Peak Systolic Gradient (mmHg) Measurements at 8 Years Post-implant | 8 years post-implant | Peak systolic gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. The data summary will be stratified by valve size. |
| Subject's Average Mean Systolic Gradient (mmHg) Measurements at 8 Years Post-implant. | 8 years post-implant | Mean systolic gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Mean gradient values depend on the size and type of valve. The data summary will be stratified by valve size. |
| Subject's Average Effective Orifice Area Measurements at 8 Years Post-implant. | 8 years post-implant | Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. The data summary will be stratified by valve size. |
| Subject's Average Effective Orifice Area Index (EOAI) Measurements at 8 Years Post-implant. | 8 years post-implant | Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. The data summary will be stratified by valve size. |
| Subject's Average Performance Index Measurements at 8 Years Post-implant. | 8 years post-implant | Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. The data summary will be stratified by valve size. |
| Subject's Average Cardiac Output Measurements at 8 Years Post-implant. | 8 years post-implant | The amount of blood the heart pumps through the circulatory system in a minute. The data summary will be stratified by valve size. |
| Subject's Average Cardiac Index Measurements at 8 Years Post-implant. | 8 years post-implant | Cardiac index is an assessment that divides the cardiac output from left ventricle in one minute by the person's body surface area (BSA), thus relating heart performance to the size of the individual. The data summary will be stratified by valve size. |
| Subject's Amount of Aortic Valvular Regurgitation at 8 Years Post-Implant. | 8 years post-implant | Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. |
| Percent of Early Adverse Events | 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. |
| Subject's Average Red Blood Cells Count Over Time. | 6 months and annually for 8 years post-implant | Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen. |
| Subject's Average Hematocrit Percentage Over Time. | 6 months and annually for 8 years post-implant | 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 Hemoglobin Count Over Time. | 6 months and annually for 8 years post-implant | Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. |
| Subject's Average Platelet Count Over Time. | 6 months and annually for 8 years post-implant | Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting. |
| Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time. | 6 months and annually for 8 years post-implant | Laboratory Analysis of Serum Lactate Dehydrogenase on blood drawn from subjects; The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues. |
| Subject's Average Haptoglobin Measurement Over Time. | 6 months and annually for 8 years post-implant | Laboratory Analysis of haptoglobin on blood drawn from subjects; haptoglobin is a protein produced by the liver. |
| Subject's Average Reticulocytes Percentage Over Time. | 6 months and annually for 8 years post-implant | Laboratory Analysis of reticulocytes on blood drawn from subjects. Reticulocytes are newly produced immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood. |
| Subject's Average Score on the EQ-5D- Quality of Life Questionnaire at Baseline and 6 Months Post-Implant. | Baseline and 6 Months Post-Implant | 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 ranges from a minimum of 0 and a maximum of 100 where zero is the 'worst state imaginable' and 100 is the 'best state imaginable'. |
| Subject's Average White Blood Cell Count Measurement Over Time. | 6 months and annually for 8 years post-implant | Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection. |
| Percentage of Late Adverse Events | Events occurring >= 31 days and up through 8 years post-implant | Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event). |
| Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | 1 Year, 2 Years, 3 Years, 4 Years, 5 Years, 6 Years, 7 Years, and 8 Years post-implant | Subject's freedom from Serious Adverse Events at \> 30 days post-implant. Time to events were estimated by Kaplan-Meier method. |
Countries
Austria, Canada, Germany, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement. | 258 |
| Total | 258 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Consented but did not receive device | 25 |
| Overall Study | Death | 38 |
| Overall Study | Explanted | 10 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | On-Protocol | 67 |
| Overall Study | Other | 1 |
| Overall Study | Patient received valve-in-valve | 3 |
| Overall Study | Withdrawal by Subject | 31 |
Baseline characteristics
| Characteristic | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | — |
|---|---|---|
| Age, Continuous | 68.5 years STANDARD_DEVIATION 8.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 91 Participants | — |
| Sex: Female, Male Male | 167 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 38 / 258 |
| other Total, other adverse events | 184 / 258 |
| serious Total, serious adverse events | 211 / 258 |
Outcome results
Primary
Number of Subject's in NYHA Functional Class I or II at 8 Year Post-Implant
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).
Time frame: 8 years post-implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Number of Subject's in NYHA Functional Class I or II at 8 Year Post-Implant | Class I | 57 Participants |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Number of Subject's in NYHA Functional Class I or II at 8 Year Post-Implant | Class II | 35 Participants |
Primary
Subject's New York Heart Association (NYHA) Functional Class at 8 Years Post-Implant 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. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Time frame: 8 Years post-implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's New York Heart Association (NYHA) Functional Class at 8 Years Post-Implant Compared to Baseline | Improve | 60 Participants |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's New York Heart Association (NYHA) Functional Class at 8 Years Post-Implant Compared to Baseline | Same | 31 Participants |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's New York Heart Association (NYHA) Functional Class at 8 Years Post-Implant Compared to Baseline | Worse | 6 Participants |
Primary
Subject's Percentage of Long Term Safety Performance
Long term safety performance will be evaluated by comparing the linearized yearly rates to the objective performance criteria (OPC) referenced in the Food and Drug Administration (FDA) 1994 Draft Heart Valve Guidance. Expressed as the Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
Time frame: 31 days through 8 years post-implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Percentage of Long Term Safety Performance | Thromboembolism | 1.5 Percentage of events/late patient years |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Percentage of Long Term Safety Performance | All Hemorrhage | 2.7 Percentage of events/late patient years |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Percentage of Long Term Safety Performance | All Perivalvular Leak | 0.2 Percentage of events/late patient years |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Percentage of Long Term Safety Performance | Endocarditis | 0.4 Percentage of events/late patient years |
Secondary
Percentage of Late Adverse Events
Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
Time frame: Events occurring >= 31 days and up through 8 years post-implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percentage of Late Adverse Events | Bleeding Event | 2.7 Percentage of events/late patient years |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percentage of Late Adverse Events | Major Bleeding Event | 1.3 Percentage of events/late patient years |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percentage of Late Adverse Events | Thromboembolism | 1.5 Percentage of events/late patient years |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percentage of Late Adverse Events | Endocarditis | 0.4 Percentage of events/late patient years |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percentage of Late Adverse Events | Structural Valve Deterioration | 1.0 Percentage of events/late patient years |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percentage of Late Adverse Events | Reoperation Due to SVD | 0.6 Percentage of events/late patient years |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percentage of Late Adverse Events | Hemolysis | 0.1 Percentage of events/late patient years |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percentage of Late Adverse Events | Non-Structural Valve Deterioration | 0.3 Percentage of events/late patient years |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percentage of Late Adverse Events | Perivalvular Leak | 0.2 Percentage of events/late patient years |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percentage of Late Adverse Events | Major Perivalvular Leak | 0.1 Percentage of events/late patient years |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percentage of Late Adverse Events | Valve Thrombosis | 0.0 Percentage of events/late patient years |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percentage of Late Adverse Events | Explant | 0.5 Percentage of events/late patient years |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percentage of Late Adverse Events | Death | 2.3 Percentage of events/late patient years |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percentage of Late Adverse Events | Valve-related death | 0.5 Percentage of events/late patient years |
Secondary
Percent of Early Adverse Events
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
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Early Adverse Events | Bleeding Event | 6.2 Percentage of Early Adverse Events |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Early Adverse Events | Major Bleeding Event | 5.0 Percentage of Early Adverse Events |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Early Adverse Events | Thromboembolism | 1.9 Percentage of Early Adverse Events |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Early Adverse Events | Endocarditis | 0.0 Percentage of Early Adverse Events |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Early Adverse Events | Structural Valve Deterioration | 0.0 Percentage of Early Adverse Events |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Early Adverse Events | Reoperation Due to SVD | 0.0 Percentage of Early Adverse Events |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Early Adverse Events | Hemolysis | 0.0 Percentage of Early Adverse Events |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Early Adverse Events | Non-Structural Valve Deterioration | 0.4 Percentage of Early Adverse Events |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Early Adverse Events | Perivalvular Leak | 0.4 Percentage of Early Adverse Events |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Early Adverse Events | Major Perivalvular Leak | 0.4 Percentage of Early Adverse Events |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Early Adverse Events | Valve Thrombosis | 0.0 Percentage of Early Adverse Events |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Early Adverse Events | Explant | 1.2 Percentage of Early Adverse Events |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Early Adverse Events | Death | 0.4 Percentage of Early Adverse Events |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Early Adverse Events | Valve-related death | 0.0 Percentage of Early Adverse Events |
Secondary
Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days
Subject's freedom from Serious Adverse Events at \> 30 days post-implant. Time to events were estimated by Kaplan-Meier method.
Time frame: 1 Year, 2 Years, 3 Years, 4 Years, 5 Years, 6 Years, 7 Years, and 8 Years post-implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Hemolysis | 99.18 percentage of subjects |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Valve thrombosis | 100.0 percentage of subjects |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Reoperation | 97.63 percentage of subjects |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Thromboembolism | 96.03 percentage of subjects |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Explant | 98.04 percentage of subjects |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Perivalvular leak | 98.78 percentage of subjects |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Non-structural valve dysfunction | 98.78 percentage of subjects |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Death | 97.60 percentage of subjects |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Valve-related death | 99.60 percentage of subjects |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Endocarditis | 98.81 percentage of subjects |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Bleeding Event | 88.44 percentage of subjects |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Major perivalvular leak | 99.20 percentage of subjects |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Major Bleeding Event | 92.51 percentage of subjects |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Structural valve deterioration | 100.0 percentage of subjects |
| Magna Ease™, Model 3300TFX - 2 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Major Bleeding Event | 92.09 percentage of subjects |
| Magna Ease™, Model 3300TFX - 2 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Endocarditis | 98.39 percentage of subjects |
| Magna Ease™, Model 3300TFX - 2 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Thromboembolism | 94.32 percentage of subjects |
| Magna Ease™, Model 3300TFX - 2 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Valve-related death | 99.60 percentage of subjects |
| Magna Ease™, Model 3300TFX - 2 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Structural valve deterioration | 99.57 percentage of subjects |
| Magna Ease™, Model 3300TFX - 2 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Non-structural valve dysfunction | 98.36 percentage of subjects |
| Magna Ease™, Model 3300TFX - 2 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Reoperation | 97.21 percentage of subjects |
| Magna Ease™, Model 3300TFX - 2 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Death | 97.19 percentage of subjects |
| Magna Ease™, Model 3300TFX - 2 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Hemolysis | 99.18 percentage of subjects |
| Magna Ease™, Model 3300TFX - 2 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Explant | 97.62 percentage of subjects |
| Magna Ease™, Model 3300TFX - 2 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Major perivalvular leak | 99.20 percentage of subjects |
| Magna Ease™, Model 3300TFX - 2 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Bleeding Event | 86.76 percentage of subjects |
| Magna Ease™, Model 3300TFX - 2 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Valve thrombosis | 100.0 percentage of subjects |
| Magna Ease™, Model 3300TFX - 2 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Perivalvular leak | 98.36 percentage of subjects |
| Magna Ease™, Model 3300TFX - 3 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Non-structural valve dysfunction | 98.36 percentage of subjects |
| Magna Ease™, Model 3300TFX - 3 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Major perivalvular leak | 99.20 percentage of subjects |
| Magna Ease™, Model 3300TFX - 3 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Structural valve deterioration | 99.13 percentage of subjects |
| Magna Ease™, Model 3300TFX - 3 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Death | 95.50 percentage of subjects |
| Magna Ease™, Model 3300TFX - 3 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Valve-related death | 98.74 percentage of subjects |
| Magna Ease™, Model 3300TFX - 3 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Endocarditis | 98.39 percentage of subjects |
| Magna Ease™, Model 3300TFX - 3 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Bleeding Event | 84.13 percentage of subjects |
| Magna Ease™, Model 3300TFX - 3 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Thromboembolism | 92.56 percentage of subjects |
| Magna Ease™, Model 3300TFX - 3 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Hemolysis | 99.18 percentage of subjects |
| Magna Ease™, Model 3300TFX - 3 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Perivalvular leak | 98.36 percentage of subjects |
| Magna Ease™, Model 3300TFX - 3 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Reoperation | 96.78 percentage of subjects |
| Magna Ease™, Model 3300TFX - 3 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Major Bleeding Event | 90.33 percentage of subjects |
| Magna Ease™, Model 3300TFX - 3 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Explant | 97.19 percentage of subjects |
| Magna Ease™, Model 3300TFX - 3 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Valve thrombosis | 100.0 percentage of subjects |
| Magna Ease™, Model 3300TFX - 4 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Hemolysis | 99.18 percentage of subjects |
| Magna Ease™, Model 3300TFX - 4 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Death | 93.76 percentage of subjects |
| Magna Ease™, Model 3300TFX - 4 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Valve-related death | 98.28 percentage of subjects |
| Magna Ease™, Model 3300TFX - 4 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Reoperation | 95.89 percentage of subjects |
| Magna Ease™, Model 3300TFX - 4 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Explant | 96.30 percentage of subjects |
| Magna Ease™, Model 3300TFX - 4 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Bleeding Event | 83.22 percentage of subjects |
| Magna Ease™, Model 3300TFX - 4 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Major Bleeding Event | 90.33 percentage of subjects |
| Magna Ease™, Model 3300TFX - 4 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Thromboembolism | 92.11 percentage of subjects |
| Magna Ease™, Model 3300TFX - 4 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Endocarditis | 97.94 percentage of subjects |
| Magna Ease™, Model 3300TFX - 4 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Perivalvular leak | 98.36 percentage of subjects |
| Magna Ease™, Model 3300TFX - 4 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Major perivalvular leak | 99.20 percentage of subjects |
| Magna Ease™, Model 3300TFX - 4 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Non-structural valve dysfunction | 97.91 percentage of subjects |
| Magna Ease™, Model 3300TFX - 4 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Structural valve deterioration | 99.13 percentage of subjects |
| Magna Ease™, Model 3300TFX - 4 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Valve thrombosis | 100.0 percentage of subjects |
| Magna Ease™, Model 3300TFX - 5 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Hemolysis | 99.18 percentage of subjects |
| Magna Ease™, Model 3300TFX - 5 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Thromboembolism | 90.70 percentage of subjects |
| Magna Ease™, Model 3300TFX - 5 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Reoperation | 95.89 percentage of subjects |
| Magna Ease™, Model 3300TFX - 5 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Non-structural valve dysfunction | 97.91 percentage of subjects |
| Magna Ease™, Model 3300TFX - 5 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Bleeding Event | 81.79 percentage of subjects |
| Magna Ease™, Model 3300TFX - 5 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Perivalvular leak | 98.36 percentage of subjects |
| Magna Ease™, Model 3300TFX - 5 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Death | 91.54 percentage of subjects |
| Magna Ease™, Model 3300TFX - 5 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Endocarditis | 97.94 percentage of subjects |
| Magna Ease™, Model 3300TFX - 5 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Valve thrombosis | 100.0 percentage of subjects |
| Magna Ease™, Model 3300TFX - 5 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Major perivalvular leak | 99.20 percentage of subjects |
| Magna Ease™, Model 3300TFX - 5 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Structural valve deterioration | 99.13 percentage of subjects |
| Magna Ease™, Model 3300TFX - 5 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Explant | 96.30 percentage of subjects |
| Magna Ease™, Model 3300TFX - 5 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Valve-related death | 97.81 percentage of subjects |
| Magna Ease™, Model 3300TFX - 5 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Major Bleeding Event | 88.91 percentage of subjects |
| Magna Ease™, Model 3300TFX - 6 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Reoperation | 95.37 percentage of subjects |
| Magna Ease™, Model 3300TFX - 6 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Hemolysis | 99.18 percentage of subjects |
| Magna Ease™, Model 3300TFX - 6 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Major Bleeding Event | 88.40 percentage of subjects |
| Magna Ease™, Model 3300TFX - 6 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Valve-related death | 97.31 percentage of subjects |
| Magna Ease™, Model 3300TFX - 6 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Structural valve deterioration | 97.07 percentage of subjects |
| Magna Ease™, Model 3300TFX - 6 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Non-structural valve dysfunction | 97.91 percentage of subjects |
| Magna Ease™, Model 3300TFX - 6 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Thromboembolism | 89.68 percentage of subjects |
| Magna Ease™, Model 3300TFX - 6 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Valve thrombosis | 100.0 percentage of subjects |
| Magna Ease™, Model 3300TFX - 6 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Major perivalvular leak | 99.20 percentage of subjects |
| Magna Ease™, Model 3300TFX - 6 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Bleeding Event | 81.29 percentage of subjects |
| Magna Ease™, Model 3300TFX - 6 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Explant | 96.30 percentage of subjects |
| Magna Ease™, Model 3300TFX - 6 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Death | 89.20 percentage of subjects |
| Magna Ease™, Model 3300TFX - 6 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Endocarditis | 97.94 percentage of subjects |
| Magna Ease™, Model 3300TFX - 6 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Perivalvular leak | 98.36 percentage of subjects |
| Magna Ease™, Model 3300TFX - 7 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Death | 85.16 percentage of subjects |
| Magna Ease™, Model 3300TFX - 7 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Endocarditis | 97.27 percentage of subjects |
| Magna Ease™, Model 3300TFX - 7 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Bleeding Event | 80.63 percentage of subjects |
| Magna Ease™, Model 3300TFX - 7 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Perivalvular leak | 98.36 percentage of subjects |
| Magna Ease™, Model 3300TFX - 7 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Explant | 95.65 percentage of subjects |
| Magna Ease™, Model 3300TFX - 7 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Major perivalvular leak | 99.20 percentage of subjects |
| Magna Ease™, Model 3300TFX - 7 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Reoperation | 94.07 percentage of subjects |
| Magna Ease™, Model 3300TFX - 7 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Hemolysis | 99.18 percentage of subjects |
| Magna Ease™, Model 3300TFX - 7 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Valve-related death | 96.66 percentage of subjects |
| Magna Ease™, Model 3300TFX - 7 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Non-structural valve dysfunction | 97.91 percentage of subjects |
| Magna Ease™, Model 3300TFX - 7 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Valve thrombosis | 100.0 percentage of subjects |
| Magna Ease™, Model 3300TFX - 7 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Structural valve deterioration | 95.74 percentage of subjects |
| Magna Ease™, Model 3300TFX - 7 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Major Bleeding Event | 87.75 percentage of subjects |
| Magna Ease™, Model 3300TFX - 7 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Thromboembolism | 88.39 percentage of subjects |
| Magna Ease™, Model 3300TFX - 8 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Death | 80.69 percentage of subjects |
| Magna Ease™, Model 3300TFX - 8 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Endocarditis | 97.27 percentage of subjects |
| Magna Ease™, Model 3300TFX - 8 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Major perivalvular leak | 99.20 percentage of subjects |
| Magna Ease™, Model 3300TFX - 8 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Explant | 94.81 percentage of subjects |
| Magna Ease™, Model 3300TFX - 8 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Bleeding Event | 77.95 percentage of subjects |
| Magna Ease™, Model 3300TFX - 8 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Structural valve deterioration | 90.08 percentage of subjects |
| Magna Ease™, Model 3300TFX - 8 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Perivalvular leak | 98.36 percentage of subjects |
| Magna Ease™, Model 3300TFX - 8 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Major Bleeding Event | 85.08 percentage of subjects |
| Magna Ease™, Model 3300TFX - 8 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Thromboembolism | 86.68 percentage of subjects |
| Magna Ease™, Model 3300TFX - 8 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Valve-related death | 95.79 percentage of subjects |
| Magna Ease™, Model 3300TFX - 8 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Valve thrombosis | 100.0 percentage of subjects |
| Magna Ease™, Model 3300TFX - 8 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Non-structural valve dysfunction | 97.91 percentage of subjects |
| Magna Ease™, Model 3300TFX - 8 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Hemolysis | 99.18 percentage of subjects |
| Magna Ease™, Model 3300TFX - 8 Year Post-Implant | Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days | Reoperation | 89.83 percentage of subjects |
Secondary
Subject's Amount of Aortic Valvular Regurgitation at 8 Years Post-Implant.
Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.
Time frame: 8 years post-implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Amount of Aortic Valvular Regurgitation at 8 Years Post-Implant. | +2 Mild | 9 Participants |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Amount of Aortic Valvular Regurgitation at 8 Years Post-Implant. | 0 None | 58 Participants |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Amount of Aortic Valvular Regurgitation at 8 Years Post-Implant. | +1 Trivial | 20 Participants |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Amount of Aortic Valvular Regurgitation at 8 Years Post-Implant. | +3 Moderate | 1 Participants |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Amount of Aortic Valvular Regurgitation at 8 Years Post-Implant. | +4 Severe | 0 Participants |
Secondary
Subject's Average Cardiac Index Measurements at 8 Years Post-implant.
Cardiac index is an assessment that divides the cardiac output from left ventricle in one minute by the person's body surface area (BSA), thus relating heart performance to the size of the individual. The data summary will be stratified by valve size.
Time frame: 8 years post-implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Cardiac Index Measurements at 8 Years Post-implant. | 19 mm | 2.3 L/min/m^2 | Standard Deviation 0.22 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Cardiac Index Measurements at 8 Years Post-implant. | 21 mm | 2.9 L/min/m^2 | Standard Deviation 0.55 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Cardiac Index Measurements at 8 Years Post-implant. | 23 mm | 2.7 L/min/m^2 | Standard Deviation 0.6 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Cardiac Index Measurements at 8 Years Post-implant. | 25 mm | 2.6 L/min/m^2 | Standard Deviation 0.6 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Cardiac Index Measurements at 8 Years Post-implant. | 27 mm | 3.1 L/min/m^2 | Standard Deviation 0.91 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Cardiac Index Measurements at 8 Years Post-implant. | 29 mm | 2.6 L/min/m^2 | Standard Deviation 0.32 |
Secondary
Subject's Average Cardiac Output Measurements at 8 Years Post-implant.
The amount of blood the heart pumps through the circulatory system in a minute. The data summary will be stratified by valve size.
Time frame: 8 years post-implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Cardiac Output Measurements at 8 Years Post-implant. | 19 mm | 3.6 Liters per minute | Standard Deviation 0.32 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Cardiac Output Measurements at 8 Years Post-implant. | 21 mm | 5.2 Liters per minute | Standard Deviation 1.23 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Cardiac Output Measurements at 8 Years Post-implant. | 23 mm | 5.0 Liters per minute | Standard Deviation 1.1 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Cardiac Output Measurements at 8 Years Post-implant. | 25 mm | 5.1 Liters per minute | Standard Deviation 1.28 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Cardiac Output Measurements at 8 Years Post-implant. | 27 mm | 6.3 Liters per minute | Standard Deviation 2.1 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Cardiac Output Measurements at 8 Years Post-implant. | 29 mm | 5.3 Liters per minute | Standard Deviation 0.78 |
Secondary
Subject's Average Effective Orifice Area Index (EOAI) Measurements at 8 Years Post-implant.
Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. The data summary will be stratified by valve size.
Time frame: 8 years post-implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Effective Orifice Area Index (EOAI) Measurements at 8 Years Post-implant. | 19 mm | 0.6 centimeters squared/meters squared | Standard Deviation 0.11 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Effective Orifice Area Index (EOAI) Measurements at 8 Years Post-implant. | 21 mm | 0.7 centimeters squared/meters squared | Standard Deviation 0.2 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Effective Orifice Area Index (EOAI) Measurements at 8 Years Post-implant. | 23 mm | 0.8 centimeters squared/meters squared | Standard Deviation 0.32 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Effective Orifice Area Index (EOAI) Measurements at 8 Years Post-implant. | 25 mm | 0.8 centimeters squared/meters squared | Standard Deviation 0.21 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Effective Orifice Area Index (EOAI) Measurements at 8 Years Post-implant. | 27 mm | 1.1 centimeters squared/meters squared | Standard Deviation 0.1 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Effective Orifice Area Index (EOAI) Measurements at 8 Years Post-implant. | 29 mm | 0.9 centimeters squared/meters squared | Standard Deviation 0.24 |
Secondary
Subject's Average Effective Orifice Area Measurements at 8 Years Post-implant.
Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. The data summary will be stratified by valve size.
Time frame: 8 years post-implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Effective Orifice Area Measurements at 8 Years Post-implant. | 21 mm | 1.4 Centimeters Squared | Standard Deviation 0.4 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Effective Orifice Area Measurements at 8 Years Post-implant. | 19 mm | 1.0 Centimeters Squared | Standard Deviation 0.15 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Effective Orifice Area Measurements at 8 Years Post-implant. | 23 mm | 1.4 Centimeters Squared | Standard Deviation 0.53 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Effective Orifice Area Measurements at 8 Years Post-implant. | 25 mm | 1.7 Centimeters Squared | Standard Deviation 0.47 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Effective Orifice Area Measurements at 8 Years Post-implant. | 27 mm | 2.1 Centimeters Squared | Standard Deviation 0.32 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Effective Orifice Area Measurements at 8 Years Post-implant. | 29 mm | 1.9 Centimeters Squared | Standard Deviation 0.44 |
Secondary
Subject's Average Haptoglobin Measurement Over Time.
Laboratory Analysis of haptoglobin on blood drawn from subjects; haptoglobin is a protein produced by the liver.
Time frame: 6 months and annually for 8 years post-implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Haptoglobin Measurement Over Time. | 6 Months | 118.4 mg/dl | Standard Deviation 66.9 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Haptoglobin Measurement Over Time. | 1 Year | 114.7 mg/dl | Standard Deviation 70.7 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Haptoglobin Measurement Over Time. | 2 Years | 115.6 mg/dl | Standard Deviation 61.4 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Haptoglobin Measurement Over Time. | 3 Years | 116.3 mg/dl | Standard Deviation 58.9 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Haptoglobin Measurement Over Time. | 4 Years | 112.8 mg/dl | Standard Deviation 62.3 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Haptoglobin Measurement Over Time. | 5 Years | 127.1 mg/dl | Standard Deviation 104 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Haptoglobin Measurement Over Time. | 6 Years | 115.6 mg/dl | Standard Deviation 58.9 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Haptoglobin Measurement Over Time. | 7 Years | 125.0 mg/dl | Standard Deviation 87.4 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Haptoglobin Measurement Over Time. | 8 Years | 109.8 mg/dl | Standard Deviation 53.7 |
Secondary
Subject's Average Hematocrit Percentage Over Time.
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: 6 months and annually for 8 years post-implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Hematocrit Percentage Over Time. | 6 Months | 40.6 percentage of red blood cells | Standard Deviation 4 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Hematocrit Percentage Over Time. | 1 Year | 41.2 percentage of red blood cells | Standard Deviation 4 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Hematocrit Percentage Over Time. | 2 Years | 41.7 percentage of red blood cells | Standard Deviation 4 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Hematocrit Percentage Over Time. | 3 Years | 41.4 percentage of red blood cells | Standard Deviation 3.9 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Hematocrit Percentage Over Time. | 4 Years | 41.8 percentage of red blood cells | Standard Deviation 4.1 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Hematocrit Percentage Over Time. | 5 Years | 41.6 percentage of red blood cells | Standard Deviation 7.9 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Hematocrit Percentage Over Time. | 6 Years | 41.2 percentage of red blood cells | Standard Deviation 5.3 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Hematocrit Percentage Over Time. | 7 Years | 41.4 percentage of red blood cells | Standard Deviation 4.6 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Hematocrit Percentage Over Time. | 8 Years | 42.6 percentage of red blood cells | Standard Deviation 6.6 |
Secondary
Subject's Average Hemoglobin Count Over Time.
Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.
Time frame: 6 months and annually for 8 years post-implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Hemoglobin Count Over Time. | 6 Months | 13.7 g/dl | Standard Deviation 1.6 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Hemoglobin Count Over Time. | 1 Year | 14.0 g/dl | Standard Deviation 1.6 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Hemoglobin Count Over Time. | 2 Years | 14.1 g/dl | Standard Deviation 1.6 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Hemoglobin Count Over Time. | 3 Years | 14.0 g/dl | Standard Deviation 1.5 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Hemoglobin Count Over Time. | 4 Years | 14.1 g/dl | Standard Deviation 1.5 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Hemoglobin Count Over Time. | 5 Years | 14.0 g/dl | Standard Deviation 1.6 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Hemoglobin Count Over Time. | 6 Years | 14.0 g/dl | Standard Deviation 1.7 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Hemoglobin Count Over Time. | 7 Years | 14.0 g/dl | Standard Deviation 1.8 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Hemoglobin Count Over Time. | 8 Years | 14.3 g/dl | Standard Deviation 1.4 |
Secondary
Subject's Average Mean Systolic Gradient (mmHg) Measurements at 8 Years Post-implant.
Mean systolic gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Mean gradient values depend on the size and type of valve. The data summary will be stratified by valve size.
Time frame: 8 years post-implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Mean Systolic Gradient (mmHg) Measurements at 8 Years Post-implant. | 19 mm | 17.7 mmHg | Standard Deviation 6.38 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Mean Systolic Gradient (mmHg) Measurements at 8 Years Post-implant. | 21 mm | 17.2 mmHg | Standard Deviation 10.82 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Mean Systolic Gradient (mmHg) Measurements at 8 Years Post-implant. | 23 mm | 16.2 mmHg | Standard Deviation 10.46 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Mean Systolic Gradient (mmHg) Measurements at 8 Years Post-implant. | 25 mm | 12.7 mmHg | Standard Deviation 4.56 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Mean Systolic Gradient (mmHg) Measurements at 8 Years Post-implant. | 27 mm | 12.2 mmHg | Standard Deviation 4.51 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Mean Systolic Gradient (mmHg) Measurements at 8 Years Post-implant. | 29 mm | 13.3 mmHg | Standard Deviation 9.48 |
Secondary
Subject's Average Peak Systolic Gradient (mmHg) Measurements at 8 Years Post-implant
Peak systolic gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. The data summary will be stratified by valve size.
Time frame: 8 years post-implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Peak Systolic Gradient (mmHg) Measurements at 8 Years Post-implant | 19 mm | 24.6 mmHg | Standard Deviation 17.94 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Peak Systolic Gradient (mmHg) Measurements at 8 Years Post-implant | 21 mm | 24.7 mmHg | Standard Deviation 23.52 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Peak Systolic Gradient (mmHg) Measurements at 8 Years Post-implant | 23 mm | 26.3 mmHg | Standard Deviation 21.41 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Peak Systolic Gradient (mmHg) Measurements at 8 Years Post-implant | 25 mm | 21.6 mmHg | Standard Deviation 8.94 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Peak Systolic Gradient (mmHg) Measurements at 8 Years Post-implant | 27 mm | 22.1 mmHg | Standard Deviation 8.81 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Peak Systolic Gradient (mmHg) Measurements at 8 Years Post-implant | 29 mm | 23.1 mmHg | Standard Deviation 15.41 |
Secondary
Subject's Average Performance Index Measurements at 8 Years Post-implant.
Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. The data summary will be stratified by valve size.
Time frame: 8 years post-implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Performance Index Measurements at 8 Years Post-implant. | 19 mm | 0.5 cm^2/cm^2 | Standard Deviation 0.09 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Performance Index Measurements at 8 Years Post-implant. | 21 mm | 0.5 cm^2/cm^2 | Standard Deviation 0.14 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Performance Index Measurements at 8 Years Post-implant. | 23 mm | 0.4 cm^2/cm^2 | Standard Deviation 0.18 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Performance Index Measurements at 8 Years Post-implant. | 25 mm | 0.4 cm^2/cm^2 | Standard Deviation 0.1 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Performance Index Measurements at 8 Years Post-implant. | 27 mm | 0.4 cm^2/cm^2 | Standard Deviation 0.04 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Performance Index Measurements at 8 Years Post-implant. | 29 mm | 0.3 cm^2/cm^2 | Standard Deviation 0.09 |
Secondary
Subject's Average Platelet Count Over Time.
Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.
Time frame: 6 months and annually for 8 years post-implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Platelet Count Over Time. | 6 Months | 207.9 10^3 platelets per microliter | Standard Deviation 64.4 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Platelet Count Over Time. | 1 Year | 202.5 10^3 platelets per microliter | Standard Deviation 50.1 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Platelet Count Over Time. | 2 Years | 204.7 10^3 platelets per microliter | Standard Deviation 56.3 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Platelet Count Over Time. | 3 Years | 195.6 10^3 platelets per microliter | Standard Deviation 50.9 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Platelet Count Over Time. | 4 Years | 198.6 10^3 platelets per microliter | Standard Deviation 57.1 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Platelet Count Over Time. | 5 Years | 198.3 10^3 platelets per microliter | Standard Deviation 74.7 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Platelet Count Over Time. | 6 Years | 196.9 10^3 platelets per microliter | Standard Deviation 54.7 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Platelet Count Over Time. | 7 Years | 199.1 10^3 platelets per microliter | Standard Deviation 58.3 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Platelet Count Over Time. | 8 Years | 190.7 10^3 platelets per microliter | Standard Deviation 51.1 |
Secondary
Subject's Average Red Blood Cells Count Over Time.
Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen.
Time frame: 6 months and annually for 8 years post-implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Red Blood Cells Count Over Time. | 6 Months | 4.7 10^6 cells/microliters | Standard Deviation 0.6 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Red Blood Cells Count Over Time. | 1 Year | 4.7 10^6 cells/microliters | Standard Deviation 0.6 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Red Blood Cells Count Over Time. | 2 Years | 4.7 10^6 cells/microliters | Standard Deviation 0.5 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Red Blood Cells Count Over Time. | 3 Years | 4.6 10^6 cells/microliters | Standard Deviation 0.5 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Red Blood Cells Count Over Time. | 4 Years | 4.6 10^6 cells/microliters | Standard Deviation 0.5 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Red Blood Cells Count Over Time. | 5 Years | 4.6 10^6 cells/microliters | Standard Deviation 0.6 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Red Blood Cells Count Over Time. | 6 Years | 4.6 10^6 cells/microliters | Standard Deviation 0.5 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Red Blood Cells Count Over Time. | 7 Years | 4.7 10^6 cells/microliters | Standard Deviation 0.6 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Red Blood Cells Count Over Time. | 8 Years | 4.7 10^6 cells/microliters | Standard Deviation 0.5 |
Secondary
Subject's Average Reticulocytes Percentage Over Time.
Laboratory Analysis of reticulocytes on blood drawn from subjects. Reticulocytes are newly produced immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood.
Time frame: 6 months and annually for 8 years post-implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Reticulocytes Percentage Over Time. | 6 Months | 1.2 percentage of reticulocytes | Standard Deviation 1.5 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Reticulocytes Percentage Over Time. | 1 Year | 1.2 percentage of reticulocytes | Standard Deviation 0.5 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Reticulocytes Percentage Over Time. | 2 Years | 1.2 percentage of reticulocytes | Standard Deviation 0.5 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Reticulocytes Percentage Over Time. | 3 Years | 1.2 percentage of reticulocytes | Standard Deviation 0.5 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Reticulocytes Percentage Over Time. | 4 Years | 1.4 percentage of reticulocytes | Standard Deviation 1.3 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Reticulocytes Percentage Over Time. | 5 Years | 1.8 percentage of reticulocytes | Standard Deviation 6.2 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Reticulocytes Percentage Over Time. | 6 Years | 4.4 percentage of reticulocytes | Standard Deviation 13.4 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Reticulocytes Percentage Over Time. | 7 Years | 5.4 percentage of reticulocytes | Standard Deviation 16.5 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Reticulocytes Percentage Over Time. | 8 Years | 4.5 percentage of reticulocytes | Standard Deviation 14.8 |
Secondary
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire at Baseline and 6 Months Post-Implant.
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 ranges from a minimum of 0 and a maximum of 100 where zero is the 'worst state imaginable' and 100 is the 'best state imaginable'.
Time frame: Baseline and 6 Months Post-Implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire at Baseline and 6 Months Post-Implant. | Baseline | 75.8 units on a scale | Standard Deviation 15.1 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire at Baseline and 6 Months Post-Implant. | 6 Months Follow-up | 84.3 units on a scale | Standard Deviation 13.6 |
Secondary
Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time.
Laboratory Analysis of Serum Lactate Dehydrogenase on blood drawn from subjects; The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues.
Time frame: 6 months and annually for 8 years post-implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time. | 6 Months | 240.8 U/L | Standard Deviation 112.6 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time. | 1 Year | 235.5 U/L | Standard Deviation 103.3 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time. | 2 Years | 234.6 U/L | Standard Deviation 106.5 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time. | 3 Years | 236.1 U/L | Standard Deviation 102.3 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time. | 4 Years | 243.9 U/L | Standard Deviation 107.1 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time. | 5 Years | 236.7 U/L | Standard Deviation 94.3 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time. | 6 Years | 255.3 U/L | Standard Deviation 162.2 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time. | 7 Years | 238.2 U/L | Standard Deviation 88.5 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time. | 8 Years | 263.0 U/L | Standard Deviation 117.9 |
Secondary
Subject's Average White Blood Cell Count Measurement Over Time.
Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.
Time frame: 6 months and annually for 8 years post-implant
Population: The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average White Blood Cell Count Measurement Over Time. | 6 Months | 7.0 10^3 cells/microliters | Standard Deviation 2 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average White Blood Cell Count Measurement Over Time. | 1 Year | 6.8 10^3 cells/microliters | Standard Deviation 1.7 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average White Blood Cell Count Measurement Over Time. | 2 Years | 6.9 10^3 cells/microliters | Standard Deviation 1.7 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average White Blood Cell Count Measurement Over Time. | 3 Years | 6.9 10^3 cells/microliters | Standard Deviation 2.1 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average White Blood Cell Count Measurement Over Time. | 4 Years | 6.9 10^3 cells/microliters | Standard Deviation 2.1 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average White Blood Cell Count Measurement Over Time. | 5 Years | 6.9 10^3 cells/microliters | Standard Deviation 1.7 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average White Blood Cell Count Measurement Over Time. | 6 Years | 7.1 10^3 cells/microliters | Standard Deviation 2.3 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average White Blood Cell Count Measurement Over Time. | 7 Years | 7.2 10^3 cells/microliters | Standard Deviation 1.6 |
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | Subject's Average White Blood Cell Count Measurement Over Time. | 8 Years | 7.4 10^3 cells/microliters | Standard Deviation 2.3 |