N/A
N=329
Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol
Coronary Artery Disease · Mitral Valve Regurgitation · Mitral Valve Incompetence · Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00853632 ↗Enrolled (actual)
329
Serious AEs
85.4%
Results posted
May 2025
Primary outcome: Primary: Subject's Rate of Objective Performance Criteria Per ISO 5840-2005 - Total Number of Late Adverse Events (by Category) Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort — 2.0; 5.8; 0.3; 0.3 Linearized rate percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Edwards Lifesciences
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject's Rate of Objective Performance Criteria Per ISO 5840-2005 - Total Number of Late Adverse Events (by Category) Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort |
2.0; 5.8; 0.3; 0.3 | — |
| PRIMARY Primary Effectiveness Endpoints |
93 | — |
| SECONDARY Percent of Early Adverse Events |
2.1; 0.0; 12.2; 9.4; 0.0; 0.0 | — |
| SECONDARY Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time |
63.1; 75.4 | — |
| SECONDARY Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort |
2.0; 0.1; 5.8; 3.2; 0.3; 0.0 | — |
| SECONDARY Subject's Average Mean Gradient Measurement |
8.03; 5.70 | — |
| SECONDARY Subject's Average Peak Gradient Measurement |
18.56; 14.57 | — |
| SECONDARY Subject's Average Effective Orifice Area (EOA) Measurement |
1.39; 1.90 | — |
| SECONDARY Subject's Average Effective Orifice Area Index (EOAI) Measurement |
0.73; 1.03 | — |
| SECONDARY Subject's Average Cardiac Output Measurement |
4.70; 6.02 | — |
| SECONDARY Subject's Average Cardiac Index Measurement |
2.50; 3.32 | — |
| SECONDARY Subject's Average Left Ventricular Mass Regression |
213.21; 163.71 | — |
| SECONDARY Subject's Average Red Blood Cell Count |
4.4; 4.4; 4.3; 4.3; 4.6; 4.4 | — |
| SECONDARY Subject's Average White Blood Cell Count |
6.9; 6.9; 7.2; 7.1; 6.7; 7.1 | — |
| SECONDARY Subject's Average Hemoglobin Count |
12.4; 12.5; 12.8; 12.8; 13.7; 12.9 | — |
| SECONDARY Subject's Average Hematocrit Count |
38.0; 37.9; 38.7; 38.6; 40.7; 39.4 | — |
| SECONDARY Subject's Average Reticulocytes Percentage Over Time |
1.2; 1.4; 1.4; 1.2; 1.1; 1.4 | — |
| SECONDARY Subject's Average Platelet Count Over Time |
242.2; 218.5; 211.6; 202.0; 202.0; 224.3 | — |
| SECONDARY Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time |
241.4; 247.3; 322.5; 274.2; 300.5; 232.7 | — |
| SECONDARY Subject's Average Plasma Free Hemoglobin Over Time |
10.7; 8.3; 14.4; 17.8; 20.1; 16.3 | — |
| SECONDARY Subject's Average Haptoglobin Over Time |
118.7; 143.9; 118.0; 119.2; 70.9; 110.0 | — |
Summary
The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards® PERIMOUNT Magna Mitral Valves in patients undergoing mitral valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.
Eligibility Criteria
Inclusion Criteria
- The patient requires, as indicated in the preoperative evaluation, a replacement mitral valve.
- The patient has signed and dated the subject informed consent form prior to surgery.
- The patient is expected to survive the surgery and be discharged.
- The patient is geographically stable and agrees to attend follow-up assessments.
- The patient is 18 years or older.
Exclusion Criteria
- The patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year.
- The patient presents with active endocarditis within the last 3 months.
- The patient is pregnant or lactating.
- The patient is an intravenous drug abuser.
- The patient is currently a prison inmate.
- The patient is currently participating in a study of an investigational drug or device.
- The patient requires replacement of a native or prosthetic tricuspid or pulmonic valve.
- The patient requires replacement of a native or prosthetic aortic valve with a prosthesis other than a commercially available Carpentier-Edwards PERIMOUNT Valve (i.e. models 2700, 2700TFX, 2800, 2800TFX, 2900, 3000, 3000TFX, 3300TFX)*.
- The patient was previously enrolled in the study.
- The patient has had prior aortic, tricuspid and/or pulmonary valve surgery, which included implantation of a bioprosthetic valve or mechanical valve that will remain in situ.
Data sourced from ClinicalTrials.gov (NCT00853632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.