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

Heart Failure Clinical Trial

Official title: ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Aortic and Mitral Bioprostheses (Models 11000A and 11000M) With a New Tissue Treatment Platform (COMMENCE)

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Multicenter, prospective, single arm trial - Up to seven hundred (700) aortic valve replacement (AVR) subjects and up to one hundred seventy-five (175) mitral valve replacement (MVR) subjects at up to forty (40) clinical sites will be enrolled. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valve. Patients will be followed and assessed after implant for up to 5 years. ;

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Insufficiency
• Aortic Valve Stenosis
• Constriction, Pathologic
• Heart Failure
• Mitral Stenosis
• Mitral Valve Insufficiency
• Mitral Valve Stenosis

• NCT number: NCT01757665
• Study type: Interventional
• Source: Edwards Lifesciences
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 11, 2012
• Completion date: August 2026