ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
Public ClinicalTrials.gov record NCT01757665. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Aortic and Mitral Bioprostheses (Models 11000A and 11000M) With a New Tissue Treatment Platform (COMMENCE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01757665
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 777 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 11, 2012 (Actual)
- Primary completion
- Aug 2017 (Actual)
- Completion
- Mar 23, 2026 (Actual)
- Last update posted
- May 7, 2026
2012 – 2026
United States locations
- U.S. sites
- 29
- U.S. states
- 17
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cardiology, P.C. | Birmingham | Alabama | 35211 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| Sutter Institute for Medical Research | Sacramento | California | 95919 | — |
| Board of Trustees of the Leland Stanford Junior University | Stanford | California | 94305 | — |
| Yale-New Haven | New Haven | Connecticut | 06519 | — |
| Shands at the University of Florida | Gainesville | Florida | 32608 | — |
| Florida Hospital | Orlando | Florida | 32803 | — |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | — |
| St. Vincent Heart Center of Indiana | Indianapolis | Indiana | 46290 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| University of Maryland, Baltimore | Baltimore | Maryland | 21201 | — |
| Spectrum Health Hospital | Grand Rapids | Michigan | 49503 | — |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | — |
| Missouri Baptist Medical Center | St Louis | Missouri | 36131 | — |
| Washington University/ Barnes Jewish Hospital | St Louis | Missouri | 63110 | — |
| New York Weill Cornell Medical Center | New York | New York | 10021 | — |
| Mount Sinai Morningside | New York | New York | 10025 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| New York Presbyterian Hospital - Columbia University Medical Center | New York | New York | 10032 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| OhioHealth Research Institute | Columbus | Ohio | 43124 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| Pinnacle Health Cardiovascular Institute | Mechanicsburg | Pennsylvania | 17050 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| St. Thomas Health | Nashville | Tennessee | 37205 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Michael E. DeBakey VA Medical Center | Houston | Texas | 77030 | — |
| The Heart Hospital of Baylor Plano | Plano | Texas | 75093 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01757665, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 7, 2026 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01757665 live on ClinicalTrials.gov.