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

Last updated: May 2, 2025
Sponsor: The Leeds Teaching Hospitals NHS Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Any commercially available transcatheter aortic valve

Conservative management

Surgical explantation and aortic valve replacement

Clinical Study ID

NCT06557798
CD23/157535
  • Ages > 16
  • 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 requiringpossible 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.

Study Design

Total Participants: 550
Treatment Group(s): 3
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 surgical aortic valve replacement (SAVR) 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

  • Rigshospitalet

    Copenhagen,
    Denmark

    Active - Recruiting

  • Århus Universitetshospital

    Århus,
    Denmark

    Active - Recruiting

  • Oslo University Hospital

    Oslo,
    Norway

    Active - Recruiting

  • Royal Sussex County Hospital

    Brighton, BN2 1ES
    United Kingdom

    Active - Recruiting

  • University Hospital of Wales

    Cardiff, CF14 4XW
    United Kingdom

    Active - Recruiting

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS1 3EX
    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

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