NCT02656290

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pulmonary Valve Insufficiency
• Pulmonary Valve Degeneration
• Congenital Pulmonary Valve Abnormality

Interventions

Type	Name	Description
DEVICE	Edwards Pericardial Aortic Bioprosthesis Model 11000A	Edwards Aortic Bioprosthesis Model 11000A in the pulmonary position; a trileaflet bioprosthesis comprised of bovine pericardium

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-09-01
• Completion: 2022-11-28
• First posted: 2016-01-14
• Last updated: 2023-11-21
• Results posted: 2020-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study