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NCT01757665 · ClinicalTrials.gov registry record · NA
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
A NA study of Heart Failure and Aortic Stenosis, sponsored by Edwards Lifesciences.
- Active
- Registry status
- NA
- Development phase
- 777
- Enrollment target
- 20
- Study locations
NCT01757665: Active NA study of Heart Failure and Aortic Stenosis, sponsored by Edwards Lifesciences.
NCT01757665 is a NA study of Heart Failure and Aortic Stenosis that is active but no longer recruiting, run by Edwards Lifesciences. The registered enrollment target is 777 participants, below the 2,047-participant average among 397 other Heart Failure trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01757665, a NA study of Heart Failure and Aortic Stenosis, is active but no longer recruiting, sponsored by Edwards Lifesciences.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 777 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The rate of implanted subjects that experience structural valve deterioration (SVD) of the trial valve by the time of the post operative day (POD) 390 follow-up visit. Structural valve deterioration includes dysfunction or deterioration intrinsic to the valve. Examples of SVD includes complications such as wear, fracture, calcification, leaflet tear.
Conditions Studied
Interventions
- DEVICE Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
Study Locations (20)
New York
- New York Weill Cornell Medical Center - New York
- Mount Sinai Morningside - New York
- Icahn School of Medicine at Mount Sinai - New York
- New York Presbyterian Hospital - Columbia University Medical Center - New York
California
- University of Southern California - Los Angeles
- Sutter Institute for Medical Research - Sacramento
- Board of Trustees of the Leland Stanford Junior University - Stanford
Florida
- Shands at the University of Florida - Gainesville
- Florida Hospital - Orlando
Missouri
- Missouri Baptist Medical Center - St Louis
- Washington University/ Barnes Jewish Hospital - St Louis
Alabama
- Cardiology, P.C. - Birmingham
Connecticut
- Yale-New Haven - New Haven
Georgia
- Emory University Hospital Midtown - Atlanta
Indiana
- St. Vincent Heart Center of Indiana - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 777 participants |
| Start Date | 2012-12-11 |
| Est. Completion | 2026-08 |
| Phase | NA |
What the registry record for NCT01757665 still lists
NCT01757665 is an interventional study that assigns participants to a tested intervention. The registered 777 participants enrollment target is mid-sized for trials with a published cap, below the 2,047-participant average among 397 other Heart Failure trials with a reported enrollment target (62% lower).
The record links to 5 conditions, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M is the first listed.
NCT01757665 names 20 study sites across 13 states, led by New York, California, Florida.
Frequently Asked Questions
What is clinical trial NCT01757665 about?
NCT01757665 is a clinical study titled "ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)". 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.
What is the current status of trial NCT01757665?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 777 participants. The study started on 2012-12-11. Estimated completion is 2026-08.
What conditions does trial NCT01757665 study?
This clinical trial studies the following conditions: Heart Failure, Aortic Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency, Mitral Stenosis.
What interventions are being tested in trial NCT01757665?
The interventions under investigation include: Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M (DEVICE).
Who is sponsoring clinical trial NCT01757665?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01757665 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01757665's enrollment target sits among peer trials
777 81st of 397 higher than 317 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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