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New study checks safety of combined heart valve and aorta graft

NCT ID NCT04754217

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 260 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study will enroll male and female subjects who will be undergoing replacement of a native or prosthetic aortic heart valve and ascending aorta.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * cardiac surgery including the implant of a VAVGJ or CAVGJ for native or prosthetic valve replacement Exclusion Criteria: * anticoagulation therapy intolerant * active endocarditis * anatomical or medical, surgical, psychological or social contraindications

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

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

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