Trial Summary
What is the purpose of this trial?
The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their native or prosthetic aortic or mitral valve.
Research Team
JP
John Puskas, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
Adults needing aortic or mitral valve replacement due to heart valve disease can join this trial. They must consent to follow-up for 5 years and be able to attend assessments. Excluded are those with recent strokes, heart attacks, life-limiting diseases, severe heart failure, organ transplants, other trial participation, pregnancy plans during the trial period, multiple valve replacements/repairs outside of specified conditions or certain blood disorders.Inclusion Criteria
I am 18 years old or older.
Provides written informed consent prior to trial procedures
I am scheduled for aortic or mitral valve replacement, possibly with bypass surgery.
See 3 more
Exclusion Criteria
Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial
I need surgery that is not related to my heart.
A heart ultrasound shows something abnormal inside the heart.
See 20 more
Treatment Details
Interventions
- Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M (Bioprostheses)
Trial OverviewThe COMMENCE trial is testing Edwards Bioprostheses Models 11000A (aortic) and 11000M (mitral) in patients requiring valve replacement. It aims to ensure that changes in tissue processing and sterilization do not affect safety or effectiveness over five years post-surgery.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000MExperimental Treatment1 Intervention
Aortic/Mitral valve replacement therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Edwards Lifesciences
Lead Sponsor
Trials
188
Recruited
67,500+
Founded
1958
Headquarters
Irvine, California, U.S.
Known For
Structural Heart Innovations
Top Products
SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3
Todd Brinton
Edwards Lifesciences
Chief Medical Officer since 2023
MD from Stanford University
Bernard Zovighian
Edwards Lifesciences
Chief Executive Officer since 2023
MBA from INSEAD