Status:
COMPLETED
Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol
Lead Sponsor:
Edwards Lifesciences
Conditions:
Coronary Artery Disease
Mitral Valve Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 witho...
Detailed 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 subjec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2024
Estimated Enrollment :
329 Patients enrolled
Trial Details
Trial ID
NCT00853632
Start Date
August 1 2007
End Date
March 6 2024
Last Update
May 14 2025
Active Locations (15)
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1
Dignity Health Research Institute
Sacramento, California, United States, 95816
2
AdventHealth Orlando
Orlando, Florida, United States, 32803
3
Northwestern University Hospital
Chicago, Illinois, United States, 60611
4
University of Iowa Hospital & Clinics
Iowa City, Iowa, United States, 52242