New heart valve technology put to the test in 777 patients

NCT ID NCT01757665

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

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

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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