New heart valve shows promise in large trial

NCT ID NCT02088554

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

First seen Nov 01, 2025 · Last updated May 23, 2026 · Updated 28 times

Summary

This study tested a new artificial heart valve (Model 400 Avalus) in 1312 people with aortic valve disease, such as narrowing or leaking. The goal was to see if the valve is safe and works well by checking heart function and blood flow for up to one year after surgery. Participants had their valve replaced during open-heart surgery, and the study tracked any complications or improvements in their condition.

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Contacts and locations

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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

Conditions

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AORTIC STENOSIS