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Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 11 to 12 Eligibility criteria expanded, about 15 words · Secondary endpoints: details revised at 1 of 8 entries · Publications: details revised at 7 of 7 entries Show 3 more changesShow less
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 8 entries
    • Publications: details revised at 7 of 7 entries
  2. Study sites: 10 to 11v15
  3. Primary and study completion dates: Nov 1, 2026 to Nov 1, 2027 Study sites: 9 to 10v14 Show 1 more changeShow less
    • Study sites: 9 to 10
  4. Primary and study completion dates: Nov 1, 2025 to Nov 1, 2026v13
  5. Study sites: 7 to 9v12
Show 10 earlier versionsHide 10 earlier versions
  1. Study sites: 6 to 7v11
  2. Re-verified, no change to tracked fieldsv10
  3. Study sites: 5 to 6v9
  4. Study sites: 4 to 5v8
  5. Study sites: 3 to 4v7
  6. Study sites: 2 to 3v6
  7. Study sites: 1 to 2v5
  8. Re-verified, no change to tracked fieldsv4
  9. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Dec 15, 2023 to Feb 1, 2024v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 15, 2023 to Feb 1, 2024
  10. Start date: Nov 1, 2023 to Dec 15, 2023v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The VIVALL-2 study is a randomized trial to compare the self-expandable supra-annular Allegra and the balloon-expandable intra-annular Edwards transcatheter valve systems in patients with degenerated biological aortic surgical valve.
Trial Details
NCT Number NCT06049654
Lead Sponsor Fundación EPIC
Conditions Aortic Valve Stenosis, Structural Valve Deterioration
Enrollment 104 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov