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

NCT01757665 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 777

Last updated 2026-05-07

Study results available
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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.

Conditions

  • Aortic Stenosis
  • Mitral Stenosis
  • Aortic Valve Insufficiency
  • Mitral Valve Insufficiency
  • Heart Failure

Interventions

DEVICE

Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M

Implant of an aortic valve, Model 11000A or mitral valve, Model 11000M

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • John Puskas, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-11
Primary Completion
2017-08-31
Completion
2026-03-23
FDA Device
Yes

Countries

  • United States
  • Canada
  • Poland

Study Locations

More Related Trials

Entities

Diseases

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 NCT01757665 on ClinicalTrials.gov