ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)

NAActive, not recruitingINTERVENTIONAL
Enrollment

777

Participants

Timeline

Start Date

December 11, 2012

Primary Completion Date

August 31, 2017

Study Completion Date

August 31, 2026

Conditions
Aortic StenosisMitral StenosisAortic Valve InsufficiencyMitral Valve InsufficiencyHeart Failure
Interventions
DEVICE

Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M

Implant of an aortic valve, Model 11000A or mitral valve, Model 11000M

Trial Locations (32)

10021

New York Weill Cornell Medical Center, New York

10025

Mount Sinai Morningside, New York

10029

Icahn School of Medicine at Mount Sinai, New York

10032

New York Presbyterian Hospital - Columbia University Medical Center, New York

17050

Pinnacle Health Cardiovascular Institute, Mechanicsburg

19104

Hospital of the University of Pennsylvania, Philadelphia

21201

University of Maryland, Baltimore, Baltimore

30308

Emory University Hospital Midtown, Atlanta

32608

Shands at the University of Florida, Gainesville

32803

Florida Hospital, Orlando

35211

Cardiology, P.C., Birmingham

36131

Missouri Baptist Medical Center, St Louis

37205

St. Thomas Health, Nashville

38801

North Mississippi Medical Center, Tupelo

43124

OhioHealth Research Institute, Columbus

43210

The Ohio State University Wexner Medical Center, Columbus

44195

Cleveland Clinic Foundation, Cleveland

46290

St. Vincent Heart Center of Indiana, Indianapolis

49503

Spectrum Health Hospital, Grand Rapids

63110

Washington University/ Barnes Jewish Hospital, St Louis

66160

University of Kansas Medical Center, Kansas City

75093

The Heart Hospital of Baylor Plano, Plano

77030

Baylor College of Medicine, Houston

Michael E. DeBakey VA Medical Center, Houston

84132

University of Utah, Salt Lake City

90033

University of Southern California, Los Angeles

94305

Board of Trustees of the Leland Stanford Junior University, Stanford

95919

Sutter Institute for Medical Research, Sacramento

06519

Yale-New Haven, New Haven

G1V 4G5

Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec

31-202

Krakowski Szpital Specjalistyczny im. Jana Pawla II, Krakow

04-628

The Cardinal Stefan Wyszynski Institute of Cardiology, Warsaw

Sponsors
All Listed Sponsors
lead

Edwards Lifesciences

INDUSTRY