Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT00853632

Run by

Edwards Lifesciences

People needed

329

Starts

2007-08-01

Expected to finish

2024-03-06

Last updated by the study team

2025-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dignity Health Research Institute — Sacramento, California, United States
• AdventHealth Orlando — Orlando, Florida, United States
• Northwestern University Hospital — Chicago, Illinois, United States
• University of Iowa Hospital & Clinics — Iowa City, Iowa, United States
• Iowa Heart Medical Center — West Des Moines, Iowa, United States
• University of Michigan Medical School — Ann Arbor, Michigan, United States
• Spectrum Health Hospitals — Grand Rapids, Michigan, United States
• Missouri Baptist Medical Center — St Louis, Missouri, United States
• North Shore University Hospital, NY — Manhasset, New York, United States
• Long Island Jewish Medical Center — New Hyde Park, New York, United States
• Krankenhaus Hietzing — Vienna, Austria
• St. Paul's Hospital — Vancouver, British Columbia, Canada
• Institut Universitaire de Cardiologie et de Pneumologie de Quebec — Québec, Canada
• University Clinica Eppendorf — Hamburg, Germany
• Klinikum der Friedrich Schiller University — Jena, Germany

Full record on ClinicalTrials.gov

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