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

Last updated: January 30, 2026
Sponsor: The Leeds Teaching Hospitals NHS Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Any commercially available transcatheter aortic valve

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

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 transcatheter aortic valve
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 2624886,
    Denmark

    Active - Recruiting

  • Århus Universitetshospital

    Aarhus 2624652,
    Denmark

    Active - Recruiting

  • Rigshospitalet

    Copenhagen,
    Denmark

    Site Not Available

  • Rigshospitalet

    Copenhagen 2618425,
    Denmark

    Active - Recruiting

  • Århus Universitetshospital

    Århus,
    Denmark

    Site Not Available

  • HUS Helsinki University Hospital

    Helsinki,
    Finland

    Site Not Available

  • HUS Helsinki University Hospital

    Helsinki 658225,
    Finland

    Active - Recruiting

  • Turku University Hospital

    Turku,
    Finland

    Site Not Available

  • Turku University Hospital

    Turku 633679,
    Finland

    Active - Recruiting

  • Clinical Saint Augustin - Elsan

    Bordeaux 3031582,
    France

    Active - Recruiting

  • Brest University Hospital Centre

    Brest 3030300,
    France

    Active - Recruiting

  • Henri Mondor University Hospital

    Créteil 3022530,
    France

    Active - Recruiting

  • ICPS Hôpital privé Jacques-Cartier

    Massy 2995206,
    France

    Active - Recruiting

  • Hospital Marie Lannelongue

    Paris 2988507,
    France

    Active - Recruiting

  • Institute Mutualiste Montsouris

    Paris 2988507,
    France

    Active - Recruiting

  • Les Hospital Universitaires de Strasbourg

    Strasbourg 2973783,
    France

    Active - Recruiting

  • Clinique Pasteur Toulouse

    Toulouse 2972315,
    France

    Active - Recruiting

  • CHRU Hospitals of Tours

    Tours 2972191,
    France

    Active - Recruiting

  • Medipole Lyon-Villeurbanne

    Villeurbanne 2968254,
    France

    Active - Recruiting

  • Kerckhoff Klinik

    Bad Nauheim 2953395,
    Germany

    Active - Recruiting

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen 2953386,
    Germany

    Active - Recruiting

  • Klinikum Dortmund GmbH - St. Johannes Hospital

    Dortmund 2935517,
    Germany

    Active - Recruiting

  • Herzzentrum Dresden Universitätsklinik

    Dresden 2935022,
    Germany

    Active - Recruiting

  • Universitatsklinikum Frankfurt

    Frankfurt 2925536,
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein (UKSH)

    Kiel 2891122,
    Germany

    Active - Recruiting

  • HELIOS Herzzentrum Leipzig GmbH

    Leipzig 2879139,
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein (UKSH)

    Lübeck 2875601,
    Germany

    Active - Recruiting

  • LMU Klinikum

    München 2867711,
    Germany

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem 281184,
    Israel

    Active - Recruiting

  • Azienda Ospedaliero Universitaria (AOU) Policlinico Vittorio Emanuele

    Catania 2525068,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

    Catania 2525068,
    Italy

    Active - Recruiting

  • Centro Cardiologico Monzino

    Milan 6951411,
    Italy

    Active - Recruiting

  • IRCSS Policlinico San Donato

    San Donato Milanese 3168414,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona 3164527,
    Italy

    Active - Recruiting

  • Ospedale Borgo Trento - Azienda Ospedaliera Universitaria Integrata Verona

    Verona 3164527,
    Italy

    Active - Recruiting

  • Amphia Hospital

    Breda 2758401,
    Netherlands

    Active - Recruiting

  • Maastricht University Medical Center (MUMC)

    Maastricht 2751283,
    Netherlands

    Active - Recruiting

  • Erasmus University Medical Center

    Rotterdam,
    Netherlands

    Site Not Available

  • Erasmus University Medical Center

    Rotterdam 2747891,
    Netherlands

    Active - Recruiting

  • Haukeland Sykehus

    Bergen,
    Norway

    Site Not Available

  • Haukeland Sykehus

    Bergen 3161732,
    Norway

    Active - Recruiting

  • Oslo University Hospital

    Oslo,
    Norway

    Site Not Available

  • Oslo University Hospital

    Oslo 3143244,
    Norway

    Active - Recruiting

  • Sahlgrenska University Hospital

    Gothenburg 2711537,
    Sweden

    Active - Recruiting

  • Skånes Universitetssjukhus Lund

    Lund 2693678,
    Sweden

    Active - Recruiting

  • Nya Karolinska Sjukhuset Solna

    Solna 2675397,
    Sweden

    Active - Recruiting

  • Inselspital - Universitätsspital Bern

    Bern,
    Switzerland

    Site Not Available

  • Inselspital - Universitätsspital Bern

    Bern 2661552,
    Switzerland

    Active - Recruiting

  • Luzerner Kantonsspital

    Lucerne 2659811,
    Switzerland

    Active - Recruiting

  • Luzerner Kantonsspital

    Luzern,
    Switzerland

    Site Not Available

  • Queen Elizabeth Hospital

    Birmingham 2655603,
    United Kingdom

    Active - Recruiting

  • Royal Sussex County Hospital

    Brighton, BN2 1ES
    United Kingdom

    Site Not Available

  • Royal Sussex County Hospital

    Brighton 2654710, BN2 1ES
    United Kingdom

    Active - Recruiting

  • Bristol Royal Infirmary

    Bristol,
    United Kingdom

    Site Not Available

  • Bristol Royal Infirmary

    Bristol 2654675,
    United Kingdom

    Active - Recruiting

  • University Hospital of Wales

    Cardiff, CF14 4XW
    United Kingdom

    Site Not Available

  • University Hospital of Wales

    Cardiff 2653822, CF14 4XW
    United Kingdom

    Active - Recruiting

  • Golden Jubilee National Hospital

    Glasgow,
    United Kingdom

    Site Not Available

  • Golden Jubilee National Hospital

    Glasgow 2648579,
    United Kingdom

    Active - Recruiting

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS1 3EX
    United Kingdom

    Site Not Available

  • Leeds Teaching Hospitals NHS Trust

    Leeds 2644688, LS1 3EX
    United Kingdom

    Active - Recruiting

  • Glenfield Hospital

    Leicester 2644668,
    United Kingdom

    Active - Recruiting

  • Guys and St Thomas' NHS Foundation Trust

    London 2643743,
    United Kingdom

    Active - Recruiting

  • St. George's Hospital

    London 2643743,
    United Kingdom

    Active - Recruiting

  • Manchester Royal Infirmary

    Manchester 2643123,
    United Kingdom

    Active - Recruiting

  • Freeman Hospital

    Newcastle Upon Tyne,
    United Kingdom

    Site Not Available

  • Freeman Hospital

    Newcastle upon Tyne 2641673,
    United Kingdom

    Active - Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU
    United Kingdom

    Site Not Available

  • Oxford University Hospitals NHS Foundation Trust

    Oxford 2640729, OX3 9DU
    United Kingdom

    Active - Recruiting

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • University Hospital Southampton NHS Foundation Trust

    Southampton 2637487, SO16 6YD
    United Kingdom

    Active - Recruiting

  • New Cross Hospital

    Wolverhampton,
    United Kingdom

    Site Not Available

  • New Cross Hospital

    Wolverhampton 2633691,
    United Kingdom

    Active - Recruiting

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