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

NCT02656290 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2023-11-21

Study results available
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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.

Conditions

  • Pulmonary Valve Insufficiency
  • Pulmonary Valve Degeneration
  • Congenital 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

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Christopher Baird, MD · Boston Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-09-30
Completion
2022-11-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02656290 on ClinicalTrials.gov