Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

Edwards Lifesciences

Status

Completed

Conditions

Mitral Valve Regurgitation

Coronary Artery Disease

Heart Failure

Mitral Valve Incompetence

Treatments

Device: CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES

Study type

Interventional

Funder types

Industry

Identifiers

NCT00853632

2006-05

Details and patient eligibility

About

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.

Full description

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.

Enrollment

329 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.