NCT02656290View on ClinicalTrials.gov

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

NACompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

September 30, 2018

Study Completion Date

November 28, 2022

Conditions
Pulmonary Valve InsufficiencyPulmonary Valve DegenerationCongenital Pulmonary Valve Abnormality
Interventions
DEVICE

Edwards Pericardial Aortic Bioprosthesis Model 11000A

Edwards Aortic Bioprosthesis Model 11000A in the pulmonary position; a trileaflet bioprosthesis comprised of bovine pericardium

Trial Locations (1)

02115

Boston Children's Hospital, Boston

Sponsors
All Listed Sponsors
lead

Edwards Lifesciences

INDUSTRY