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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01757665
The ClinicalTrials.gov registry entry for NCT01757665 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 777 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,047-participant average among 397 other Heart Failure trials with a reported enrollment target (62% lower). The listed sponsor is Edwards Lifesciences, which has 57 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.