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COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement — COMMENCE-P  

Pulmonary Valve Insufficiency Clinical Trial

Official title:
Prospective, Non-Randomized, Single Arm, Multicenter Clinical Evaluation of the Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement

Clinical Trial Summary

The objective of this trial is to assess the safety and effectiveness of the Edwards Pericardial Aortic Bioprosthesis Model 11000A, in the pulmonary position in pediatric and adult subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.

Clinical Trial Description

This is a prospective, Non-Randomized, Single Arm, Multicenter study. Up to one hundred (100) pulmonary valve replacement (PVR) subjects at up to ten (10) clinical sites will be enrolled. Clinical data will be collected from at least 3 centers with data available on patients who have completed the 1 year follow-up visit. Subjects will be followed for and assessed after implant for up to 5 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02656290
Study type Interventional
Source Edwards Lifesciences
Contact
Status Completed
Phase N/A
Start date December 2015
Completion date November 28, 2022
View Details
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