An interventional study of Implantation of CEP Magna Ease Model 3300TFX in Coronary Artery Disease, Aortic Valve Disorder and Heart Failure, sponsored by Edwards Lifesciences. Completed at 13 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-17.
Sponsored by Edwards Lifesciences · Not applicable, Interventional, and Treatment
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 283 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Edwards Lifesciences is the lead sponsor of 124 studies on the registry; 19 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 32 (94%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Implantation of CEP Magna Ease Model 3300TFX
Heart Valve Surgery
Also known as: CEP Magna Ease MOdel 3300TFX
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| Started | 283 |
| Subjects implanted with device | 258 |
| Completed | 103 |
| Not completed | 180 |
| Withdrew: On-protocol | 67 |
| Withdrew: Death | 38 |
| Withdrew: Withdrawal by subject | 31 |
| Withdrew: Explanted | 10 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Patient received valve-in-valve | 3 |
| Withdrew: Other | 1 |
| Withdrew: Consented but did not receive device | 25 |
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).
| Percentage of events/late patient years | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| Thromboembolism | 1.5 |
| All Hemorrhage | 2.7 |
| All Perivalvular Leak | 0.2 |
| Endocarditis | 0.4 |
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).
| Participants | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| Class I | 57 |
| Class II | 35 |
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.
| Participants | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| Improve | 60 |
| Same | 31 |
| Worse | 6 |
Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100.
| Percentage of Early Adverse Events | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| Bleeding Event | 6.2 |
| Major Bleeding Event | 5.0 |
| Thromboembolism | 1.9 |
| Endocarditis | 0.0 |
| Structural Valve Deterioration | 0.0 |
| Reoperation Due to SVD | 0.0 |
| Hemolysis | 0.0 |
| Non-Structural Valve Deterioration | 0.4 |
| Perivalvular Leak | 0.4 |
| Major Perivalvular Leak | 0.4 |
| Valve Thrombosis | 0.0 |
| Explant | 1.2 |
| Death | 0.4 |
| Valve-related death | 0.0 |
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).
| Percentage of events/late patient years | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| Bleeding Event | 2.7 |
| Major Bleeding Event | 1.3 |
| Thromboembolism | 1.5 |
| Endocarditis | 0.4 |
| Structural Valve Deterioration | 1.0 |
| Reoperation Due to SVD | 0.6 |
| Hemolysis | 0.1 |
| Non-Structural Valve Deterioration | 0.3 |
| Perivalvular Leak | 0.2 |
| Major Perivalvular Leak | 0.1 |
| Valve Thrombosis | 0.0 |
| Explant | 0.5 |
| Death | 2.3 |
| Valve-related death | 0.5 |
Subject's freedom from Serious Adverse Events at \> 30 days post-implant. Time to events were estimated by Kaplan-Meier method.
| percentage of subjects | Magna Ease™, Model 3300TFX - 1 Year Post-Implant | Magna Ease™, Model 3300TFX - 2 Year Post-Implant | Magna Ease™, Model 3300TFX - 3 Year Post-Implant | Magna Ease™, Model 3300TFX - 4 Year Post-Implant | Magna Ease™, Model 3300TFX - 5 Year Post-Implant | Magna Ease™, Model 3300TFX - 6 Year Post-Implant | Magna Ease™, Model 3300TFX - 7 Year Post-Implant | Magna Ease™, Model 3300TFX - 8 Year Post-Implant |
|---|---|---|---|---|---|---|---|---|
| Death | 97.60 (95.71 to 99.50) | 97.19 (95.14 to 99.24) | 95.50 (92.89 to 98.10) | 93.76 (90.70 to 96.82) | 91.54 (87.98 to 95.09) | 89.20 (85.18 to 93.21) | 85.16 (80.34 to 89.98) | 80.69 (74.94 to 86.43) |
| Valve-related death | 99.60 (98.83 to 100.0) | 99.60 (98.83 to 100.0) | 98.74 (97.32 to 100.0) | 98.28 (96.61 to 99.95) | 97.81 (95.91 to 99.71) | 97.31 (95.18 to 99.44) | 96.66 (94.19 to 99.13) | 95.79 (92.81 to 98.77) |
| Reoperation | 97.63 (95.76 to 99.51) | 97.21 (95.18 to 99.25) | 96.78 (94.59 to 98.98) | 95.89 (93.39 to 98.39) | 95.89 (93.39 to 98.39) | 95.37 (92.69 to 98.06) | 94.07 (90.87 to 97.27) | 89.83 (85.09 to 94.58) |
| Explant | 98.04 (96.34 to 99.74) | 97.62 (95.74 to 99.50) | 97.19 (95.14 to 99.25) | 96.30 (93.92 to 98.68) | 96.30 (93.92 to 98.68) | 96.30 (93.92 to 98.68) | 95.65 (92.96 to 98.33) | 94.81 (91.70 to 97.93) |
| Bleeding Event | 88.44 (84.48 to 92.40) | 86.76 (82.55 to 90.98) | 84.13 (79.55 to 88.71) | 83.22 (78.51 to 87.92) | 81.79 (76.90 to 86.69) | 81.29 (76.33 to 86.25) | 80.63 (75.54 to 85.72) | 77.95 (72.20 to 83.70) |
| Major Bleeding Event | 92.51 (89.26 to 95.75) | 92.09 (88.75 to 95.42) | 90.33 (86.64 to 94.02) | 90.33 (86.64 to 94.02) | 88.91 (84.95 to 92.87) | 88.40 (84.34 to 92.47) | 87.75 (83.52 to 91.98) | 85.08 (80.02 to 90.15) |
| Thromboembolism | 96.03 (93.61 to 98.44) | 94.32 (91.43 to 97.22) | 92.56 (89.25 to 95.88) | 92.11 (88.69 to 95.52) | 90.70 (86.98 to 94.41) | 89.68 (85.75 to 93.62) | 88.39 (84.13 to 92.66) | 86.68 (81.88 to 91.47) |
| Endocarditis | 98.81 (97.47 to 100.0) | 98.39 (96.83 to 99.96) | 98.39 (96.83 to 99.96) | 97.94 (96.15 to 99.73) | 97.94 (96.15 to 99.73) | 97.94 (96.15 to 99.73) | 97.27 (95.07 to 99.48) | 97.27 (95.07 to 99.48) |
| Perivalvular leak | 98.78 (97.41 to 100.0) | 98.36 (96.77 to 99.95) | 98.36 (96.77 to 99.95) | 98.36 (96.77 to 99.95) | 98.36 (96.77 to 99.95) | 98.36 (96.77 to 99.95) | 98.36 (96.77 to 99.95) | 98.36 (96.77 to 99.95) |
| Major perivalvular leak | 99.20 (98.09 to 100.0) | 99.20 (98.09 to 100.0) | 99.20 (98.09 to 100.0) | 99.20 (98.09 to 100.0) | 99.20 (98.09 to 100.0) | 99.20 (98.09 to 100.0) | 99.20 (98.09 to 100.0) | 99.20 (98.09 to 100.0) |
| Hemolysis | 99.18 (98.04 to 100.0) | 99.18 (98.04 to 100.0) | 99.18 (98.04 to 100.0) | 99.18 (98.04 to 100.0) | 99.18 (98.04 to 100.0) | 99.18 (98.04 to 100.0) | 99.18 (98.04 to 100.0) | 99.18 (98.04 to 100.0) |
| Non-structural valve dysfunction | 98.78 (97.41 to 100.0) | 98.36 (96.77 to 99.95) | 98.36 (96.77 to 99.95) | 97.91 (96.09 to 99.73) | 97.91 (96.09 to 99.73) | 97.91 (96.09 to 99.73) | 97.91 (96.09 to 99.73) | 97.91 (96.09 to 99.73) |
| Structural valve deterioration | 100.0 (100.0 to 100.0) | 99.57 (98.74 to 100.0) | 99.13 (97.94 to 100.0) | 99.13 (97.94 to 100.0) | 99.13 (97.94 to 100.0) | 97.07 (94.75 to 99.39) | 95.74 (92.81 to 98.67) | 90.08 (84.74 to 95.42) |
| Valve thrombosis | 100.0 (100.0 to 100.0) | 100.0 (100.0 to 100.0) | 100.0 (100.0 to 100.0) | 100.0 (100.0 to 100.0) | 100.0 (100.0 to 100.0) | 100.0 (100.0 to 100.0) | 100.0 (100.0 to 100.0) | 100.0 (100.0 to 100.0) |
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.
| mmHg | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| 19 mm | 24.6 ± 17.94 |
| 21 mm | 24.7 ± 23.52 |
| 23 mm | 26.3 ± 21.41 |
| 25 mm | 21.6 ± 8.94 |
| 27 mm | 22.1 ± 8.81 |
| 29 mm | 23.1 ± 15.41 |
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.
| mmHg | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| 19 mm | 17.7 ± 6.38 |
| 21 mm | 17.2 ± 10.82 |
| 23 mm | 16.2 ± 10.46 |
| 25 mm | 12.7 ± 4.56 |
| 27 mm | 12.2 ± 4.51 |
| 29 mm | 13.3 ± 9.48 |
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.
| Centimeters Squared | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| 19 mm | 1.0 ± 0.15 |
| 21 mm | 1.4 ± 0.40 |
| 23 mm | 1.4 ± 0.53 |
| 25 mm | 1.7 ± 0.47 |
| 27 mm | 2.1 ± 0.32 |
| 29 mm | 1.9 ± 0.44 |
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.
| centimeters squared/meters squared | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| 19 mm | 0.6 ± 0.11 |
| 21 mm | 0.7 ± 0.20 |
| 23 mm | 0.8 ± 0.32 |
| 25 mm | 0.8 ± 0.21 |
| 27 mm | 1.1 ± 0.10 |
| 29 mm | 0.9 ± 0.24 |
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.
| cm^2/cm^2 | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| 19 mm | 0.5 ± 0.09 |
| 21 mm | 0.5 ± 0.14 |
| 23 mm | 0.4 ± 0.18 |
| 25 mm | 0.4 ± 0.10 |
| 27 mm | 0.4 ± 0.04 |
| 29 mm | 0.3 ± 0.09 |
The amount of blood the heart pumps through the circulatory system in a minute. The data summary will be stratified by valve size.
| Liters per minute | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| 19 mm | 3.6 ± 0.32 |
| 21 mm | 5.2 ± 1.23 |
| 23 mm | 5.0 ± 1.10 |
| 25 mm | 5.1 ± 1.28 |
| 27 mm | 6.3 ± 2.10 |
| 29 mm | 5.3 ± 0.78 |
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.
| L/min/m^2 | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| 19 mm | 2.3 ± 0.22 |
| 21 mm | 2.9 ± 0.55 |
| 23 mm | 2.7 ± 0.60 |
| 25 mm | 2.6 ± 0.60 |
| 27 mm | 3.1 ± 0.91 |
| 29 mm | 2.6 ± 0.32 |
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.
| Participants | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| 0 None | 58 |
| +1 Trivial | 20 |
| +2 Mild | 9 |
| +3 Moderate | 1 |
| +4 Severe | 0 |
Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.
| 10^3 cells/microliters | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| 6 Months | 7.0 ± 2.0 |
| 1 Year | 6.8 ± 1.7 |
| 2 Years | 6.9 ± 1.7 |
| 3 Years | 6.9 ± 2.1 |
| 4 Years | 6.9 ± 2.1 |
| 5 Years | 6.9 ± 1.7 |
| 6 Years | 7.1 ± 2.3 |
| 7 Years | 7.2 ± 1.6 |
| 8 Years | 7.4 ± 2.3 |
Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen.
| 10^6 cells/microliters | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| 6 Months | 4.7 ± 0.6 |
| 1 Year | 4.7 ± 0.6 |
| 2 Years | 4.7 ± 0.5 |
| 3 Years | 4.6 ± 0.5 |
| 4 Years | 4.6 ± 0.5 |
| 5 Years | 4.6 ± 0.6 |
| 6 Years | 4.6 ± 0.5 |
| 7 Years | 4.7 ± 0.6 |
| 8 Years | 4.7 ± 0.5 |
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.
| percentage of red blood cells | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| 6 Months | 40.6 ± 4.0 |
| 1 Year | 41.2 ± 4.0 |
| 2 Years | 41.7 ± 4.0 |
| 3 Years | 41.4 ± 3.9 |
| 4 Years | 41.8 ± 4.1 |
| 5 Years | 41.6 ± 7.9 |
| 6 Years | 41.2 ± 5.3 |
| 7 Years | 41.4 ± 4.6 |
| 8 Years | 42.6 ± 6.6 |
Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.
| g/dl | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| 6 Months | 13.7 ± 1.6 |
| 1 Year | 14.0 ± 1.6 |
| 2 Years | 14.1 ± 1.6 |
| 3 Years | 14.0 ± 1.5 |
| 4 Years | 14.1 ± 1.5 |
| 5 Years | 14.0 ± 1.6 |
| 6 Years | 14.0 ± 1.7 |
| 7 Years | 14.0 ± 1.8 |
| 8 Years | 14.3 ± 1.4 |
Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.
| 10^3 platelets per microliter | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| 6 Months | 207.9 ± 64.4 |
| 1 Year | 202.5 ± 50.1 |
| 2 Years | 204.7 ± 56.3 |
| 3 Years | 195.6 ± 50.9 |
| 4 Years | 198.6 ± 57.1 |
| 5 Years | 198.3 ± 74.7 |
| 6 Years | 196.9 ± 54.7 |
| 7 Years | 199.1 ± 58.3 |
| 8 Years | 190.7 ± 51.1 |
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.
| U/L | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| 6 Months | 240.8 ± 112.6 |
| 1 Year | 235.5 ± 103.3 |
| 2 Years | 234.6 ± 106.5 |
| 3 Years | 236.1 ± 102.3 |
| 4 Years | 243.9 ± 107.1 |
| 5 Years | 236.7 ± 94.3 |
| 6 Years | 255.3 ± 162.2 |
| 7 Years | 238.2 ± 88.5 |
| 8 Years | 263.0 ± 117.9 |
Laboratory Analysis of haptoglobin on blood drawn from subjects; haptoglobin is a protein produced by the liver.
| mg/dl | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| 6 Months | 118.4 ± 66.9 |
| 1 Year | 114.7 ± 70.7 |
| 2 Years | 115.6 ± 61.4 |
| 3 Years | 116.3 ± 58.9 |
| 4 Years | 112.8 ± 62.3 |
| 5 Years | 127.1 ± 104.0 |
| 6 Years | 115.6 ± 58.9 |
| 7 Years | 125.0 ± 87.4 |
| 8 Years | 109.8 ± 53.7 |
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.
| percentage of reticulocytes | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| 6 Months | 1.2 ± 1.5 |
| 1 Year | 1.2 ± 0.5 |
| 2 Years | 1.2 ± 0.5 |
| 3 Years | 1.2 ± 0.5 |
| 4 Years | 1.4 ± 1.3 |
| 5 Years | 1.8 ± 6.2 |
| 6 Years | 4.4 ± 13.4 |
| 7 Years | 5.4 ± 16.5 |
| 8 Years | 4.5 ± 14.8 |
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'.
| units on a scale | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| Baseline | 75.8 ± 15.1 |
| 6 Months Follow-up | 84.3 ± 13.6 |
Collected over Events occurring from baseline through eight years post implant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX | 38/258 (14.7%) | 211/258 (81.8%) | 184/258 (71.3%) |
| Event | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| ArrhythmiaCardiac disorders | 87/258 |
| OtherGeneral disorders | 63/258 |
| Infection / InflammationInfections and infestations | 40/258 |
| Pleural EffusionCardiac disorders | 37/258 |
| Bleeding - MajorBlood and lymphatic system disorders | 32/258 |
| CancerGeneral disorders | 27/258 |
| Respiratory ComplicationRespiratory, thoracic and mediastinal disorders | 27/258 |
| Gastro-Intestinal ComplicationGastrointestinal disorders | 26/258 |
| AnemiaBlood and lymphatic system disorders | 20/258 |
| Pericardial EffusionCardiac disorders | 20/258 |
| Event | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| OtherGeneral disorders | 84/258 |
| ArrhythmiaCardiac disorders | 58/258 |
| Infection / InflammationInfections and infestations | 42/258 |
| Pleural EffusionCardiac disorders | 36/258 |
| Pericardial EffusionCardiac disorders | 17/258 |
| Cardiac Conduction DisturbanceCardiac disorders | 15/258 |
| Respiratory ComplicationRespiratory, thoracic and mediastinal disorders | 15/258 |
| Bleeding - MinorBlood and lymphatic system disorders | 12/258 |
| Vision DisorderEye disorders | 11/258 |
| Gastro-Intestinal ComplicationGastrointestinal disorders | 10/258 |
The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.
| Age, Continuous(years) | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| Mean | 68.5 ± 8.8 |
| Sex: Female, Male(Participants) | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|---|
| Female | 91 |
| Male | 167 |
| Race and Ethnicity Not Collected(Participants) | Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX |
|---|
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Edwards Lifesciences