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New heart valve technology put to the test in 777 patients

NCT ID NCT01757665

Disease control Sponsor: Edwards Lifesciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a new way of processing tissue for Edwards heart valves is safe and works well. 777 adults who needed a new aortic or mitral valve took part. Researchers checked for valve problems like wear or calcification over about a year, and will follow patients for up to 5 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Edwards pericardial aortic and mitral bioprostheses (Models 11000A and 11000M)
What this could lead to
If successful, this could confirm that the new tissue treatment makes heart valves safer and more durable for patients needing valve replacement.
What could go wrong
This is an early-stage study without a comparison group, so results may not prove the new valves are better than existing ones. Valve deterioration or other complications could still occur.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

777 people

The number who actually took part.

Started

Dec 2012

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Eligibility Criteria: Inclusion Criteria: 1. Is 18 years or older 2. Provides written informed consent prior to trial procedures 3. Agrees to attend all follow-up assessments for up to 5 years and is willing to comply with specified follow-up evaluations at clinical investigational sites that are participating in the COMMENCE trial and/or obtain the protocol-specified diagnostic tests at centers that are under the same IRB or the same healthcare system 4. Diagnosed with aortic or mitral valve disease requiring valve replacement based on pre- operative evaluation 5. Scheduled to undergo planned aortic or mitral valve replacement with or without concomitant bypass surgery 6. Scheduled to undergo planned aortic valve replacement with or without resection and replacement of the ascending aorta from the sinotubular junction and without the need for circulatory arrest for hemi arch or arch replacement Exclusion criteria: A subject meeting any of the following criteria shall be excluded: 1. Requires emergency surgery 2. Requires planned multiple valve replacement/ repair (with the exception of mitral valve replacement with tricuspid valve repair) 3. Has prior valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ 4. Requires a surgical procedure outside of the cardiac area (e.g. vascular bypass) 5. Requires surgical replacement of the aortic root 6. Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months to the scheduled aortic or mitral valve replacement surgery 7. Has renal insufficiency as determined by creatinine (S-Cr) level ≥ 2.5 mg/dL or end -stage renal disease requiring chronic dialysis at screening visit 8. Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months (180 days) prior to planned valve surgery 9. Has acute myocardial infarction (MI) within 30 days prior to planned valve surgery 10. Has presence of non-cardiac disease limiting life expectancy to less than 12 months 11. Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM) 12. Diagnosed with abnormal calcium metabolism and hyperparathyroidism 13. Exhibits left ventricular ejection fraction ≤ 20% as validated by diagnostic procedure prior to planned valve surgery 14. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation 15. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery 16. Documented leukopenia (WBC \< 3.5x 10³/μL), acute anemia (Hgb \< 10.0 gm/dL or 6 mmol/L) or thrombocytopenia (platelet count \< 50x 10³/μL) accompanied by history of bleeding diathesis and coagulopathy 17. Has prior organ transplant or is currently an organ transplant candidate 18. Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial 19. Was previously implanted with trial device (Model 11000A or Model 11000M) 20. Pregnant (female subject of childbearing potential only), lactating or planning to become pregnant during the duration of participation in trial 21. Currently incarcerated or unable to give voluntary informed consent 22. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant 23. Requires concomitant left ventricular assist device (LVAD) placement

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Conditions

The condition(s) this trial relates to.

aortic valve disorder aortic valve insufficiency aortic valve stenosis heart failure mitral valve disorder mitral valve insufficiency mitral valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic stenosis Aortic valve insufficiency Heart failure Mitral stenosis Mitral valve insufficiency

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Board of Trustees of the Leland Stanford Junior University

    Stanford, California, 94305, United States

  • Cardiology, P.C.

    Birmingham, Alabama, 35211, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308, United States

  • Florida Hospital

    Orlando, Florida, 32803, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec

    Québec, G1V 4G5, Canada

  • Krakowski Szpital Specjalistyczny im. Jana Pawla II

    Krakow, 31-202, Poland

  • Michael E. DeBakey VA Medical Center

    Houston, Texas, 77030, United States

  • Missouri Baptist Medical Center

    St Louis, Missouri, 36131, United States

  • Mount Sinai Morningside

    New York, New York, 10025, United States

  • New York Presbyterian Hospital - Columbia University Medical Center

    New York, New York, 10032, United States

  • New York Weill Cornell Medical Center

    New York, New York, 10021, United States

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801, United States

  • OhioHealth Research Institute

    Columbus, Ohio, 43124, United States

  • Pinnacle Health Cardiovascular Institute

    Mechanicsburg, Pennsylvania, 17050, United States

  • Shands at the University of Florida

    Gainesville, Florida, 32608, United States

  • Spectrum Health Hospital

    Grand Rapids, Michigan, 49503, United States

  • St. Thomas Health

    Nashville, Tennessee, 37205, United States

  • St. Vincent Heart Center of Indiana

    Indianapolis, Indiana, 46290, United States

  • Sutter Institute for Medical Research

    Sacramento, California, 95919, United States

  • The Cardinal Stefan Wyszynski Institute of Cardiology

    Warsaw, 04-628, Poland

  • The Heart Hospital of Baylor Plano

    Plano, Texas, 75093, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Maryland, Baltimore

    Baltimore, Maryland, 21201, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • Washington University/ Barnes Jewish Hospital

    St Louis, Missouri, 63110, United States

  • Yale-New Haven

    New Haven, Connecticut, 06519, United States

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