REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure

Last updated: June 22, 2026
Sponsor: The Leeds Teaching Hospitals NHS Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication

Any commercially available transcatheter aortic valve

Conservative management

Clinical Study ID

NCT06557798
CD23/157535
  • Ages > 18
  • All Genders

Study Summary

Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and/or leaking. Although TAVI is a safe and effective treatment for a faulty aortic heart valve, the new TAVI valve will not last forever. Because it is a 'tissue' valve (made from the lining of a cow or pig heart), the valve will fail after a period of time as the tissue degenerates.

When the TAVI valve fails, a viable treatment option is to perform a 'Redo TAVI' procedure, implanting a second TAVI valve inside the first failing valve.

The main purpose of this study is to carefully evaluate patients being treated by Redo TAVI in order to document the short-term and long-term outcomes of the procedure. The study will also obtain information about which factors predict those outcomes.

The study will also assess outcomes in patients who present with TAVI valve failure but are not suitable for Redo TAVI, and instead are treated either by open-heart surgery and surgical aortic valve replacement, or by medical therapy (medication).

The study will provide doctors the information they need to understand the best way to treat patients who present with TAVI valve failure, and in particular how to perform Redo TAVI procedures with the best possible outcomes for patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Bio-prosthetic Valve Failure (BVF) of a Transcatheter Aortic Valve requiring possible reintervention

Exclusion

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 otherwisevulnerable

  6. Pregnant or nursing

Study Design

Total Participants: 550
Treatment Group(s): 4
Primary Treatment: Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication
Phase:
Study Start date:
December 12, 2024
Estimated Completion Date:
March 31, 2033

Study Description

To determine the acute and long-term outcomes of Redo Transcatheter Aortic Valve Implantation (TAVI) for the treatment of Bioprosthetic Valve Failure (BVF) affecting Transcatheter Aortic Heart Valves (THVs)

To determine the factors which predict the acute and long-term outcomes of Redo TAVI

To determine the proportion of patients presenting with BVF affecting THVs who are deemed unsuitable for Redo TAVI by the Heart Team

To determine the acute and long-term outcomes of surgical explantation and aortic valve replacement (AVR) for the treatment of BVF affecting THVs

To determine the survival of patients presenting with BVF affecting THVs who are managed conservatively - including optimal medical therapy (OMT) +/- balloon aortic valvuloplasty (BAV)

Connect with a study center

  • Aalborg Universitethospital

    Aalborg,
    Denmark

    Active - Recruiting

  • Århus Universitetshospital

    Aarhus,
    Denmark

    Active - Recruiting

  • Rigshospitalet

    Copenhagen,
    Denmark

    Active - Recruiting

  • HUS Helsinki University Hospital

    Helsinki,
    Finland

    Active - Recruiting

  • Turku University Hospital

    Turku,
    Finland

    Active - Recruiting

  • Clinical Saint Augustin - Elsan

    Bordeaux,
    France

    Active - Recruiting

  • Brest University Hospital Centre

    Brest,
    France

    Active - Recruiting

  • Henri Mondor University Hospital

    Créteil,
    France

    Active - Recruiting

  • ICPS Hôpital privé Jacques-Cartier

    Massy,
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier,
    France

    Active - Recruiting

  • University Hospital of Nimes

    Nîmes,
    France

    Active - Recruiting

  • Hospital Marie Lannelongue

    Paris,
    France

    Active - Recruiting

  • Institute Mutualiste Montsouris

    Paris,
    France

    Active - Recruiting

  • Institute Mutualiste Montsouris

    Paris 2988507,
    France

    Active - Recruiting

  • Les Hospital Universitaires de Strasbourg

    Strasbourg,
    France

    Active - Recruiting

  • Clinique Pasteur Toulouse

    Toulouse,
    France

    Active - Recruiting

  • CHRU Hospitals of Tours

    Tours,
    France

    Active - Recruiting

  • Medipole Lyon-Villeurbanne

    Villeurbanne,
    France

    Active - Recruiting

  • Kerckhoff Klinik

    Bad Nauheim,
    Germany

    Active - Recruiting

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen,
    Germany

    Active - Recruiting

  • Deutsches Herzzentrum Berlin

    Berlin,
    Germany

    Site Not Available

  • Universitatsklinikum Koln (AoR)

    Cologne,
    Germany

    Active - Recruiting

  • Klinikum Dortmund GmbH - St. Johannes Hospital

    Dortmund,
    Germany

    Active - Recruiting

  • Herzzentrum Dresden Universitätsklinik

    Dresden,
    Germany

    Active - Recruiting

  • Universitatsklinikum Dusseldorf (University Hospital Dusseldorf)

    Düsseldorf,
    Germany

    Active - Recruiting

  • Universitatsklinikum Frankfurt

    Frankfurt,
    Germany

    Active - Recruiting

  • Asklepios Klinik St. Georg

    Hamburg,
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein (UKSH)

    Kiel,
    Germany

    Active - Recruiting

  • HELIOS Herzzentrum Leipzig GmbH

    Leipzig,
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein (UKSH)

    Lübeck,
    Germany

    Active - Recruiting

  • LMU Klinikum

    München,
    Germany

    Active - Recruiting

  • Universitatsklinikum Ulm (University Hospital Ulm)

    Ulm,
    Germany

    Active - Recruiting

  • Edith Wolfson Medical Center

    Holon,
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem,
    Israel

    Active - Recruiting

  • Rabin Medical Center - Belinson Campus

    Petah Tikva,
    Israel

    Active - Recruiting

  • ASST Spedali Civili Di Brescia

    Brescia,
    Italy

    Active - Recruiting

  • Fondazione Poliambulanza Istituto Ospedaliero

    Brescia,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

    Catania,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria (AOU) Policlinico Vittorio Emanuele

    Catania 2525068,
    Italy

    Active - Recruiting

  • Ospedale San Martino - IRCCS Ospedale Policlinico

    Genova,
    Italy

    Active - Recruiting

  • Centro Cardiologico Monzino

    Milan,
    Italy

    Active - Recruiting

  • Humanitas Research Hospital - RCCS Istituto Clinico Humanitas di Milano

    Milan,
    Italy

    Site Not Available

  • IRCCS Ospedale San Raffaele

    Milan,
    Italy

    Active - Recruiting

  • Istituto Mediterraneo per i Trapianti Ismett IRCCS

    Palermo,
    Italy

    Active - Recruiting

  • IRCSS Policlinico San Donato

    San Donato Milanese,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino,
    Italy

    Active - Recruiting

  • Ospedale Borgo Trento - Azienda Ospedaliera Universitaria Integrata Verona

    Verona,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona 3164527,
    Italy

    Active - Recruiting

  • Amphia Hospital

    Breda,
    Netherlands

    Active - Recruiting

  • Maastricht University Medical Center (MUMC)

    Maastricht,
    Netherlands

    Active - Recruiting

  • Radboud Universitair Medisch Centrum

    Nijmegen,
    Netherlands

    Site Not Available

  • Erasmus University Medical Center

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Haukeland Sykehus

    Bergen,
    Norway

    Active - Recruiting

  • Oslo University Hospital

    Oslo,
    Norway

    Active - Recruiting

  • Sahlgrenska University Hospital

    Gothenburg,
    Sweden

    Active - Recruiting

  • Skånes Universitetssjukhus Lund

    Lund,
    Sweden

    Active - Recruiting

  • Nya Karolinska Sjukhuset Solna

    Solna,
    Sweden

    Active - Recruiting

  • Uppsala University

    Uppsala,
    Sweden

    Active - Recruiting

  • Inselspital - Universitätsspital Bern

    Bern,
    Switzerland

    Active - Recruiting

  • Luzerner Kantonsspital

    Lucerne,
    Switzerland

    Active - Recruiting

  • Queen Elizabeth Hospital

    Birmingham,
    United Kingdom

    Active - Recruiting

  • Royal Sussex County Hospital

    Brighton, BN2 1ES
    United Kingdom

    Active - Recruiting

  • Bristol Royal Infirmary

    Bristol,
    United Kingdom

    Active - Recruiting

  • University Hospital of Wales

    Cardiff, CF14 4XW
    United Kingdom

    Active - Recruiting

  • Golden Jubilee National Hospital

    Glasgow,
    United Kingdom

    Active - Recruiting

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS1 3EX
    United Kingdom

    Active - Recruiting

  • Glenfield Hospital

    Leicester,
    United Kingdom

    Active - Recruiting

  • Guys and St Thomas' NHS Foundation Trust

    London,
    United Kingdom

    Active - Recruiting

  • St. George's Hospital

    London,
    United Kingdom

    Active - Recruiting

  • St. George's Hospital

    London 2643743,
    United Kingdom

    Active - Recruiting

  • Manchester Royal Infirmary

    Manchester,
    United Kingdom

    Active - Recruiting

  • Freeman Hospital

    Newcastle upon Tyne,
    United Kingdom

    Active - Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU
    United Kingdom

    Active - Recruiting

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD
    United Kingdom

    Active - Recruiting

  • New Cross Hospital

    Wolverhampton,
    United Kingdom

    Active - Recruiting

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