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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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

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

Primary outcome measure(s)

• REVALVE success (Redo TAVI) — 30 days
  Correct positioning of a single prosthetic heart valve into the proper anatomic location, intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3 m/s, Doppler velocity index ≥0.25. aortic regurgitation \< moderate), Freedom from mortality, coronary obstruction, unplanned coronary revascularisation, surgery or intervention related to the device
• Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (Redo TAVI) — 12 months
  Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes
• Valve Academic Research Consortium 3 (VARC3) Early Safety (EXPLANT) — 30 days
  Composite outcome of freedom from: death/stroke/VARC 3-4 bleeding/major vascular, access-related, or cardiac structural complication/AKI 3 or 4/moderate or severe AR/new permanent pacemaker/device-related surgery or intervention
• Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (EXPLANT) — 12 months
  Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes
• Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (OMT) — 12 months
  Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes

Trial sites (75)

+ 35 more sites — see the full list on the official registry below.

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