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Prospective, Non-Randomized, Multicenter Clinical Evaluation Of The Edwards Pericardial Aortic And Mitral Bioprostheses, Model 11000A & 11000M With New Tissue Treatment Platform (COMMENCE TRIAL)

Clinical Trial Details

The Edwards Pericardial Aortic and Mitral Bioprostheses are indicated for patients who require replacement of their native or prosthetic heart valve. 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. 

Patients are followed and assessed after implant for up to 5 years. 

Key Eligibility: 
  • Males and females, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valve

Study contact by location

Upper East Side - Manhattan

Contact(s)

Nathan Palaparthi
212-746-5194
ntp2001@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1212013316

ClinicalTrials.gov:

NCT01757665

Status

Not Yet Recruiting

Age Group

Adult

Sponsor