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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Leeds Teaching Hospitals NHS Trust

About this trial

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

Qualifiers

None

Disqualifiers

Bio-prosthetic Valve Failure due solely to paravalvular aortic regurgitation

Active endocarditis

Untreated acute valve thrombosis

Life-expectancy less than 1 year

Trial design

Treatments tested in this trial

  • Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication
  • Surgical explantation and aortic valve replacement
  • Conservative management

Treatment groups

550 Participants
are divided into 3 treatment groups

Locations

71
Denmark
Aalborg Universitethospital Aalborg Denmark
Århus Universitetshospital Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Finland
HUS Helsinki University Hospital Helsinki Finland

Sponsors and collaborators

The Leeds Teaching Hospitals NHS Trust

Lead sponsor

Medtronic

Collaborator

NAMSA

Collaborator