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New study checks safety of combined heart valve and aorta graft

NCT ID NCT04754217

Recruiting now Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

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

Summary

This study is testing a device called a valved graft, which replaces both the aortic valve and the ascending aorta in one surgery. It includes 260 people with aortic valve disease, an enlarged aorta, or aortic dissection. The goal is to see how safe and effective the device is by tracking deaths and the need for repeat procedures over time.

What this could mean

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

Active substance

Valved graft device (VAVGJ or CAVGJ) for replacing the aortic valve and ascending aorta

What this could lead to

If successful, this could confirm that the valved graft is a safe and effective option for people needing replacement of both the aortic valve and ascending aorta.

What could go wrong

This is an observational post-market study, not a randomized trial, so results may not prove the device is better than alternatives. Risks include complications from surgery, such as bleeding, infection, or device failure.

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.

aneurysm or dilatation of ascending aorta Aortic Dissection Aortic Valve Disease aortic valve disorder

As listed by the trial registrant

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

AORTIC DISSECTION AORTIC VALVE DISEASE ASCENDING AORTA ABNORMALITY

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • CHRU Lille

    RECRUITING

    Lille, 59037, France

  • CHU de Besancon - Jean Minjoz

    RECRUITING

    Besançon, 25030, France

  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

    ACTIVE_NOT_RECRUITING

    Lodz, 92-213, Poland

  • Deutsches Herzzentrum Berlin

    RECRUITING

    Berlin, 13353, Germany

  • Groupe Hospitalier Bichat - Claude Bernard

    RECRUITING

    Paris, 75877, France

  • Herz-und Diabetes Zentrum NRW

    RECRUITING

    Bad Oeynhausen, 32545, Germany

  • Hospital Universitario Son Espases

    RECRUITING

    Palma de Mallorca, 07120, Spain

  • Hospital Universitario del Vinalopó

    RECRUITING

    Elche, 03293, Spain

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • James Cook University Hospital

    RECRUITING

    Middlesbrough, TS43BW, United Kingdom

  • Klinik Floridsdorf

    RECRUITING

    Vienna, 1012, Austria

  • Klinikum Links der Weser

    RECRUITING

    Bremen, 28277, Germany

  • Krakowski Szpital Specjalistyczny im. Jana Pawla II

    RECRUITING

    Krakow, 31-202, Poland

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, 30625, Germany

  • Mission Health & Hospitals

    WITHDRAWN

    Asheville, North Carolina, 28801, United States

  • Onassis Cardiac Surgery Center

    RECRUITING

    Athens, 17674, Greece

  • Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

  • Policlinico S.Orsola-Malpighi

    RECRUITING

    Bologna, 40138, Italy

  • Policlinico San Donato

    RECRUITING

    San Donato Milanese, 20097, Italy

  • Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • The Cardinal Stefan Wyszynski Institute of Cardiology

    RECRUITING

    Warsaw, 04-628, Poland

  • University Hospital - Univ. of Alabama at Birmingham (UAB)

    WITHDRAWN

    Birmingham, Alabama, 35294, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48104, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Wojewodzki Szpital Zespolony w Kielcach

    WITHDRAWN

    Kielce, 25-736, Poland