Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol
United States329 participantsStarted 2007-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
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
Timeframe: Events occurring ≥ 31 days and up through 8 years post-implant