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New heart valve shows promise in large trial

NCT ID NCT02088554

Ongoing Disease control Sponsor: Medtronic Cardiac Surgery Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new surgical heart valve (Model 400) in over 1,300 people with aortic valve disease. The valve is designed to replace the damaged aortic valve and improve blood flow. Researchers are checking how safe the valve is and how well it works over one year, looking at heart function and complication rates.

What this could mean

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

Active substance

Model 400 aortic valve bioprosthesis (a replacement heart valve made from cow tissue)

What this could lead to

If successful, this valve could offer a safe and effective option for people needing aortic valve replacement, improving heart function and quality of life.

What could go wrong

This is a single-arm study without a comparison group, so results may not prove superiority over existing valves. Risks include typical valve-related complications like blood clots, infection, or valve failure over time.

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 insufficiency aortic valve stenosis

As listed by the trial registrant

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

AORTIC STENOSIS

Contacts and locations

Locations

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215-4330, United States

  • Cardiothoracic and Vascular Surgeons (CTVS)

    Austin, Texas, 78756-4080, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195-0001, United States

  • Deutsches Herzzentrum München

    Munich, München, DE 80636, Germany

  • Erasmus MC

    Rotterdam, 3015 CE, Netherlands

  • Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital

    London, SE1 7EH, United Kingdom

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • Herzzentrum Leipzig GmbH

    Leipzig, 04289, Germany

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Hôpital Bichat - Claude Bernard

    Paris, 75018, France

  • Hôpital Cardiologique du Haut-Lévêque

    Bordeaux, 33604, France

  • Inselspital - Universitätsspital Bern

    Bern, 3010, Switzerland

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

    Québec, G1V 4G5, Canada

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, 2333 ZA, Netherlands

  • London Health Sciences Centre - University Campus

    London, Ontario, N6A 5A5, Canada

  • Maimonides Medical Center

    Brooklyn, New York, 11219, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407-1139, United States

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8, Canada

  • New York-Presbyterian Hospital/Columbia University Medical Center

    New York, New York, 10032, United States

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73135, United States

  • Ospedale San Raffaele - Milano

    Milan, 20132, Italy

  • Piedmont Hospital

    Atlanta, Georgia, 30309, United States

  • ProMedica Toledo Hospital

    Toledo, Ohio, 43606, United States

  • Riverside Methodist Hospital (OhioHealth)

    Columbus, Ohio, 43214, United States

  • The Mount Sinai Medical Center

    New York, New York, 10029, United States

  • Toronto General Hospital

    Toronto, M5G 2C4, Canada

  • Uniklinik Köln

    Cologne, Köln, 50924, Germany

  • University of Colorado Hospital

    Aurora, Colorado, 80045-2545, United States

  • University of Florida Shands

    Gainesville, Florida, 32610, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of Michigan Cardiovascular Center

    Ann Arbor, Michigan, 48109-5853, United States

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7, Canada

  • University of Southern California (USC) University Hospital

    Los Angeles, California, 90033-5313, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195-0001, United States

  • Universitäts Klinikum Frankfurt - Goethe-Universität

    Frankfurt, 60590, Germany

  • UniversitätsSpital Zürich

    Zurich, 8091, Switzerland