Less invasive heart valve replacement tested against open surgery

NCT ID NCT01586910

Ongoing Disease control Sponsor: Medtronic Cardiovascular Source: ClinicalTrials.gov ↗

First seen Nov 01, 2025 · Last updated Jun 23, 2026 · Updated 36 times

Summary

This study compared two treatments for severe aortic stenosis, a condition where the heart's main valve tightens and restricts blood flow. About 1,700 patients at intermediate surgical risk were randomly assigned to either a less invasive catheter-based valve replacement (TAVI) or traditional open-heart surgery. The goal was to see if TAVI is as safe and effective as surgery in preventing death and disabling stroke.

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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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Contacts and locations

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Locations

Abbott NW - MN Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States
Alegent Creighton Health Research Center

Omaha, Nebraska, 68124, United States
Amphia Hospital Breda

Breda, Netherlands
Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States
Banner Good Samaritan Medical Center

Phoenix, Arizona, 85006, United States
Baylor Heart and Vascular Hospital

Dallas, Texas, 75226, United States
Bern University Hospital

Bern, Switzerland
Beth Israel Deaconess Medical Center, Inc.

Boston, Massachusetts, 02215, United States
Bon Secours St. Mary's Hospital

Richmond, Virginia, 23226, United States
Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States
Carolinas HealthCare System

Charlotte, North Carolina, 28203, United States
Cedars-Sinai Medical Center

Hollywood, California, 90048, United States
Columbia University Medical Center

New York, New York, 10032, United States
Cooper University Hospital

Camden, New Jersey, 08103, United States
Delray Medical Center

Delray Beach, Florida, 33484, United States
Detroit Medical Center

Detroit, Michigan, 48201-2018, United States
Deutsches Herzzentrum Muenchen

Munich, Germany
Duke University Medical Center

Durham, North Carolina, 27710, United States
El Camino Hospital

Mountain View, California, 94040, United States
Emory University

Atlanta, Georgia, 30308, United States
Erasmus Medical Center - Rotterdam

Rotterdam, Netherlands
Geisinger Medical Center

Danville, Pennsylvania, 17822, United States
Glenfield Hospital, Leicester, UK

Leicester, LE5 4PW, United Kingdom
Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States
Hartford Hospital

Hartford, Connecticut, 06102, United States
Henry Ford

Detroit, Michigan, 48202, United States
Hospital Universitario Central de Asturias

Oviedo, Spain
Intermountain Medical Center

Murray, Utah, 84107, United States
Iowa Heart Center / Mercy Medical Center

West Des Moines, Iowa, 50266, United States
Karolinska Universitetssjukhuset Stockholm

Stockholm, 171 76, Sweden
Keck Medical Center of USC

Los Angeles, California, 90033, United States
Leeds General Infirmary

Leeds, United Kingdom
Lenox Hill Hospital

New York, New York, 10075, United States
London Health Sciences Centre, University Hospital

London, Ontario, Canada
Loyola University of Chicago

Maywood, Illinois, 60153, United States
Mayo Clinic - St. Mary's Hospital

Rochester, Minnesota, 55905, United States
McGill University Health Center - Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada
Medisch Centrum Leeuwarden

Leeuwarden, Netherlands
Montreal Heart Institute

Montreal, Canada
Morristown Medical Center

Morristown, New Jersey, 07960, United States
Morton Plant Hospital

Clearwater, Florida, 33756, United States
Mount Sinai School of Medicine

New York, New York, 10029, United States
New York University School of Medicine

New York, New York, 10016, United States
North Shore University Hospital

Manhasset, New York, 11030, United States
Oklahoma Heart Institute

Oklahoma City, Oklahoma, 73120, United States
Piedmont Healthcare, Inc.

Atlanta, Georgia, 30309, United States
Pinnacle Health Cardiovascular Institute

Wormleysburg, Pennsylvania, 17043, United States
Rigshospitalet

Copenhagen, Denmark
Saint Luke's Hospital/MAHI

Kansas City, Missouri, 64111, United States
Scripps Green Hospital

La Jolla, California, 92037, United States
Sentara Cardiovascular

Norfolk, Virginia, 23507, United States
Servicio de Cardiologia del Hospital Virgen de la Victoria

Málaga, Spain
Southern California Permenente Medical Group

Pasadena, California, 91101, United States
Spectrum Health Hospitals

Grand Rapids, Michigan, 49503, United States
St. Antonius Hospital, R & D Cardiology

Nieuwegein, Netherlands
St. Francis Hospital

Roslyn, New York, 11576, United States
St. George's Hospital London

London, SW170QT, United Kingdom
St. John Hospital & Medical Center

Detroit, Michigan, 48236, United States
St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 46290, United States
Stanford University Medical Center

Stanford, California, 94305, United States
Stern Cardiovascular

Memphis, Tennessee, 38120, United States
Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada
The Heart Hospital - Baylor Plano

Plano, Texas, 75093, United States
The Johns Hopkins University

Baltimore, Maryland, 21205, United States
The Methodist DeBakey Heart & Vascular Center

Houston, Texas, 77030, United States
The Ohio State University

Columbus, Ohio, 43210, United States
The OhioHealth Research Institute

Columbus, Ohio, 43214, United States
The Queen's Medical Center

Honolulu, Hawaii, 96813, United States
Toronto General Hospital (University Health Network)

Toronto, Ontario, M5G 2C4, Canada
Universitatsspital Zurich

Zurich, Switzerland
University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States
University of Kansas Hospital

Kansas City, Kansas, 66160, United States
University of Miami

Coral Gables, Florida, 33146, United States
University of Michigan Health Systems

Ann Arbor, Michigan, 48109-5864, United States
University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States
University of Rochester

Rochester, New York, 14642, United States
University of Vermont

Burlington, Vermont, 05401, United States
Universitäts-Herzzentrum Freiburg • Bad Krozingen

Bad Krozingen, 79106, Germany
Universitätsklinikum Bonn

Bonn, Germany
VA Palo Alto Health Care System

Palo Alto, California, 94304, United States
Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States
Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States
Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States
Winthrop University Hospital

Mineola, New York, 11501, United States
Yale New Haven Hospital

New Haven, Connecticut, 06520-8047, United States

What this could mean

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

Active substance

Medtronic CoreValve System (TAVI device) and surgical aortic valve replacement

What this could lead to

If successful, this trial could confirm that TAVI is a safe and effective alternative to open-heart surgery for patients at intermediate surgical risk, potentially reducing recovery time and complications.

What could go wrong

This is a large but completed trial; results may show no major advantage over surgery, and risks like stroke or valve failure remain. Individual outcomes vary.

Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

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

SEVERE AORTIC STENOSIS