Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Second Time's the charm? new study tests replacing heart valves again without surgery

NCT ID NCT06557798

Disease control Sponsor: The Leeds Teaching Hospitals NHS Trust 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 26, 2026 · Updated 4 times

Summary

This study follows 550 patients whose first TAVI heart valve has failed. Researchers will compare a second TAVI procedure (redo TAVI) with open-heart surgery or medication alone. The goal is to see which approach works best and why, helping doctors make better decisions for future patients.

What this could mean

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

Active substance
Transcatheter aortic valve (Edwards or Medtronic)
What this could lead to
If successful, this could establish redo TAVI as a safe, effective standard treatment for patients whose first TAVI valve fails, avoiding open-heart surgery.
What could go wrong
This is an observational study, not a randomized trial, so results may not prove superiority. Redo TAVI carries risks like coronary obstruction or valve leakage, and long-term outcomes are still unknown.

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 550 people

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

Started

Dec 2024

Expected to finish

Mar 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

All patients presenting to the Heart Team with bio-prosthetic valve failure affecting a transcatheter aortic valve

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: 1\. Bio-prosthetic Valve Failure (BVF) of a Transcatheter Aortic Valve requiring possible reintervention Exclusion Criteria: 1. Bio-prosthetic Valve Failure due solely to paravalvular aortic regurgitation 2. Active endocarditis 3. Untreated acute valve thrombosis 4. Life-expectancy less than 1 year 5. Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable 6. Pregnant or nursing

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Aortic valve stenosis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Aortic valve stenosis

How to take part

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

  1. The places running it

    71 sites in 11 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

  • ASST Spedali Civili Di Brescia

    RECRUITING

    Brescia, Italy

  • Aalborg Universitethospital

    RECRUITING

    Aalborg, Denmark

  • Amphia Hospital

    RECRUITING

    Breda, Netherlands

  • Asklepios Klinik St. Georg

    RECRUITING

    Hamburg, Germany

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    RECRUITING

    Torino, Italy

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

    RECRUITING

    Catania, Italy

  • Brest University Hospital Centre

    RECRUITING

    Brest, France

  • Bristol Royal Infirmary

    RECRUITING

    Bristol, United Kingdom

  • CHRU Hospitals of Tours

    RECRUITING

    Tours, France

  • Centre Hospitalier Universitaire de Montpellier

    RECRUITING

    Montpellier, France

  • Centre Hospitalier Universitaire de Toulouse, Hospital Rangueil

    RECRUITING

    Toulouse, France

  • Centro Cardiologico Monzino

    RECRUITING

    Milan, Italy

  • Clinical Saint Augustin - Elsan

    RECRUITING

    Bordeaux, France

  • Clinique Pasteur Toulouse

    RECRUITING

    Toulouse, France

  • Deutsches Herzzentrum Berlin

    WITHDRAWN

    Berlin, Germany

  • Deutsches Herzzentrum München (German Heartcentre Munich)

    RECRUITING

    München, Germany

  • Edith Wolfson Medical Center

    RECRUITING

    Holon, Israel

  • Erasmus University Medical Center

    RECRUITING

    Rotterdam, Netherlands

  • Fondazione Poliambulanza Istituto Ospedaliero

    RECRUITING

    Brescia, Italy

  • Freeman Hospital

    RECRUITING

    Newcastle upon Tyne, United Kingdom

  • Glenfield Hospital

    RECRUITING

    Leicester, United Kingdom

  • Golden Jubilee National Hospital

    RECRUITING

    Glasgow, United Kingdom

  • Guys and St Thomas' NHS Foundation Trust

    RECRUITING

    London, United Kingdom

  • HELIOS Herzzentrum Leipzig GmbH

    RECRUITING

    Leipzig, Germany

  • HUS Helsinki University Hospital

    RECRUITING

    Helsinki, Finland

  • Haukeland Sykehus

    RECRUITING

    Bergen, Norway

  • Henri Mondor University Hospital

    RECRUITING

    Créteil, France

  • Herz- und Diabeteszentrum NRW

    RECRUITING

    Bad Oeynhausen, Germany

  • Herzzentrum Dresden Universitätsklinik

    RECRUITING

    Dresden, Germany

  • Hospital Marie Lannelongue

    RECRUITING

    Paris, France

  • Humanitas Research Hospital - RCCS Istituto Clinico Humanitas di Milano

    WITHDRAWN

    Milan, Italy

  • ICPS Hôpital privé Jacques-Cartier

    RECRUITING

    Massy, France

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, Italy

  • IRCSS Policlinico San Donato

    RECRUITING

    San Donato Milanese, Italy

  • Inselspital - Universitätsspital Bern

    RECRUITING

    Bern, Switzerland

  • Institute Mutualiste Montsouris

    RECRUITING

    Paris, France

  • Istituto Mediterraneo per i Trapianti Ismett IRCCS

    RECRUITING

    Palermo, Italy

  • Kerckhoff Klinik

    RECRUITING

    Bad Nauheim, Germany

  • Klinikum Dortmund GmbH - St. Johannes Hospital

    RECRUITING

    Dortmund, Germany

  • LMU Klinikum

    RECRUITING

    München, Germany

  • Leeds Teaching Hospitals NHS Trust

    RECRUITING

    Leeds, LS1 3EX, United Kingdom

  • Les Hospital Universitaires de Strasbourg

    RECRUITING

    Strasbourg, France

  • Luzerner Kantonsspital

    RECRUITING

    Lucerne, Switzerland

  • Maastricht University Medical Center (MUMC)

    RECRUITING

    Maastricht, Netherlands

  • Manchester Royal Infirmary

    WITHDRAWN

    Manchester, United Kingdom

  • Medipole Lyon-Villeurbanne

    RECRUITING

    Villeurbanne, France

  • NCT - Saint-Gatien - Alliance

    RECRUITING

    Saint-Cyr-sur-Loire, France

  • New Cross Hospital

    RECRUITING

    Wolverhampton, United Kingdom

  • Nya Karolinska Sjukhuset Solna

    RECRUITING

    Solna, Sweden

  • Oslo University Hospital

    RECRUITING

    Oslo, Norway

  • Ospedale Borgo Trento - Azienda Ospedaliera Universitaria Integrata Verona

    RECRUITING

    Verona, Italy

  • Ospedale San Martino - IRCCS Ospedale Policlinico

    RECRUITING

    Genova, Italy

  • Oxford University Hospitals NHS Foundation Trust

    RECRUITING

    Oxford, OX3 9DU, United Kingdom

  • Queen Elizabeth Hospital

    RECRUITING

    Birmingham, United Kingdom

  • Rabin Medical Center - Belinson Campus

    RECRUITING

    Petah Tikva, Israel

  • Radboud Universitair Medisch Centrum

    WITHDRAWN

    Nijmegen, Netherlands

  • Rigshospitalet

    RECRUITING

    Copenhagen, Denmark

  • Royal Sussex County Hospital

    RECRUITING

    Brighton, BN2 1ES, United Kingdom

  • Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, Sweden

  • Shaare Zedek Medical Center

    RECRUITING

    Jerusalem, Israel

  • Skånes Universitetssjukhus Lund

    RECRUITING

    Lund, Sweden

  • St. George's Hospital

    RECRUITING

    London, United Kingdom

  • Turku University Hospital

    RECRUITING

    Turku, Finland

  • Universitatsklinikum Dusseldorf (University Hospital Dusseldorf)

    RECRUITING

    Düsseldorf, Germany

  • Universitatsklinikum Frankfurt

    RECRUITING

    Frankfurt, Germany

  • Universitatsklinikum Koln (AoR)

    RECRUITING

    Cologne, Germany

  • Universitatsklinikum Tubingen

    RECRUITING

    Tübingen, Germany

  • Universitatsklinikum Ulm (University Hospital Ulm)

    RECRUITING

    Ulm, Germany

  • University Hospital Southampton NHS Foundation Trust

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

  • University Hospital of Nimes

    RECRUITING

    Nîmes, France

  • University Hospital of Wales

    RECRUITING

    Cardiff, CF14 4XW, United Kingdom

  • Universitätsklinikum Schleswig-Holstein (UKSH)

    RECRUITING

    Kiel, Germany

  • Universitätsklinikum Schleswig-Holstein (UKSH)

    RECRUITING

    Lübeck, Germany

  • Uppsala University

    RECRUITING

    Uppsala, Sweden

  • Århus Universitetshospital

    RECRUITING

    Aarhus, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.