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

Study acronym: REVALVE
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Site details revised at 1 of 75 sitesv17
  2. Trial sites expanded: 71 → 75 locationsv16
  3. Study sites: 69 to 71v15
  4. Trial sites expanded: 61 → 69 locationsv14
  5. Trial sites expanded: 53 → 61 locationsv13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 52 to 53v12
  2. Study sites: 42 to 52v11 Show 4 more changesShow less
    • Interventions: Any commercially available transcatheter aortic valve (Device), Conservative management (Other), Surgical explantation and aortic valve… to Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication (Device)…
    • Secondary endpoints: 18 to 12
    • Eligibility criteria expanded, about 3 words
    • Study description shortened, about 1 word
  3. Study sites: 21 to 42v10
  4. Study sites: 18 to 21v9
  5. Study sites: 14 to 18v8
  6. Study sites: 13 to 14v7
  7. Study sites: 8 to 13v6
  8. Study sites: 5 to 8v5
  9. Study sites: 1 to 5v4
  10. Start date changed from estimate of Feb 2025 to Dec 12, 2024v3
  11. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 2024 to Feb 2025
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06557798
Lead Sponsor The Leeds Teaching Hospitals NHS Trust
Collaborators: Medtronic, NAMSA
Conditions
(from sponsor)		 Aortic Valve Stenosis
Related terms Aortic Valve Stenosis
Enrollment 550 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov