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

NCT06557798 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 550

Last updated 2026-05-13

No results posted yet for this 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.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

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

Redo TAVI will be performed using any commercially available Edwards or Medtronic transcatheter aortic valve platforms that have the TAV-in-TAV (Redo TAVI) indication according to the preferences of the local team in keeping with standard clinical care.

PROCEDURE

Surgical explantation and aortic valve replacement

Surgical explantation of all or part of the index transcatheter aortic valve, with open implantation of a new surgical or transcatheter aortic valve replacement will be performed according to the preferences of the local team in keeping with standard clinical care. Any commercially available approved surgical or transcatheter aortic valve may be used. Additional surgery, such as aortic root replacement, root enlargement, CABG, mitral valve repair/replacement, etc. will be performed at the discretion of the local team.

OTHER

Conservative management

Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • NAMSA

    collaborator OTHER

  • The Leeds Teaching Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Daniel Blackman, MD · Leeds Teaching Hospitals NHS Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-12
Primary Completion
2027-06-30
Completion
2033-03-31

Countries

  • Denmark
  • Finland
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06557798 on ClinicalTrials.gov