Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a prospective, single-arm, multi-center study to be conducted in the US and outside the US (OUS). Approximately 250 subjects are planned to be enrolled to obtain long term data from 101 subjects at 8 years post implant of the Magna mitral valve. Of these 250, approximately 38 (15%) are anticipated to be simultaneous aortic and mitral replacements. Subject enrollment will not start in the US before obtaining FDA approval of this post market study. Assessments will be obtained for the preoperative and operative visits, and postoperatively at discharge, six months, 1-year and annually thereafter for a minimum of 8 years. Subject's demographics (date of birth, sex), physical assessment (heart rate, height, weight, systolic and diastolic blood pressures), New York Heart Association (NYHA) functional class, cardiac rhythm, cardiovascular medical history/risk factors, non-cardiovascular conditions, previous cardiovascular procedures/interventions, antithromboembolic and lipid lowering medications and coagulation profile. Blood data will be collected from each subject preoperatively, at 6 months and annually post implant through 8 year follow-ups. Echocardiographic evaluation required for each subject preoperatively, at discharge, 6 months (between 3-6 months), 1, 2, 4, 6, and 8 year follow-ups. A QOL survey (EQ-5D) will be completed by the subject pre-operatively and at the 6-month follow-up visit.

Official Title
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Carpentier-Edwards® Perimount Magna® Mitral Pericardial Bioprostheses Models 7000/7000 TFX and Carpentier-Edwards® Perimount Magna® Mitral Ease™ Pericardial Bioprostheses Models 7200TFX and 7300/7300TFX

Conditions
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Coronary Artery Disease, Mitral Valve Regurgitation, Mitral Valve Incompetence, Heart Failure

Intervention / Treatment
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* Device: CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Device - CEP Mitral Valve<br> | Device: CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES<br>* Mitral valve replacement<br>* Other names: Magna Mitral 7000/7000TFX, Magna Mitral Ease 7200TFX, 7300/7300TFX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoints | Long term safety performance will be evaluated by comparing the linearized rates listed below to the objective performance criteria referenced in ISO 5840- 2005, Cardiovascular Implants-Cardiac Valve Prostheses. Thromboembolism All Hemorrhage All Perivalvular Leak Endocarditis | Long term safety performance | 
| Primary Effectiveness Endpoints | The primary effectiveness endpoint will be the percentage of subjects in NYHA functional classification I or II at 8 years post-implant. | 8 years post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Safety Endpoints | Early & late linearized & actuarial analysis of: Thromboembolism Valve thrombosis All hemorrhage Major hemorrhage All perivalvular leak Major perivalvular leak Endocarditis Hemolysis Structural valve deterioration Non-structural valve dysfunction Reoperation Explant Death Valve-related death | Long term safety performance | 
| Secondary Safety Endpoints | Blood studies including white blood count, red blood count, hematocrit, plasma free hemoglobin (or haptoglobin and SLDH), platelet and reticulocyte counts will be used to evaluate the rate of hemolysis and adverse events at the 6 month, 1 year and annual follow-up visits. | 6 month, 1 year and annual follow-up visits | 
| Secondary Effectiveness Endpoints | The secondary Effectiveness endpoints will be: Hemodynamic Performance by echocardiography at 8 years post implant, which includes: Peak Gradient Mean Gradient Effective Orifice Area Effective Orifice Area Index Performance Index Cardiac Output Cardiac Index Severity of Valvular Regurgitation LV Mass Regression | 8 years post-implant | 
| Secondary Effectiveness Endpoints | Quality of Life Survey (EQ-5D) at 6 month post index procedure as compared to preoperative baseline. | 6 months post-implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PERIMOUNT, Mitral valve, pericardial bioprostheses, bovine pericardial leaflets, mitral valve replacement, mitral valve regurgitation, Heart valve disease