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TVMR With the INNOVALVE System Trial - Early Feasibility Study

Study acronym: TWIST-EFS
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Jul 1, 2026 → Jul 1, 2028
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Edwards Lifesciences

Record History

  1. Primary completion pushed from Jul 1, 2026 to Jul 1, 2028 Primary endpoint(s) modified · Enrollment increased: 65 → 85 participants · Completion pushed from Jul 1, 2031 to Jul 1, 2034 · 2 more Show 5 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 65 → 85 participants
    • Completion pushed from Jul 1, 2031 to Jul 1, 2034
    • Study sites: 20 to 21
    • Eligibility criteria expanded, about 6 words
  2. Trial sites expanded: 17 → 20 locationsv15
  3. Study sites: 13 to 17v14
  4. Study sites: 12 to 13v13
  5. Interventions: Innovalve MR system (Device) to INNOVALVE system (Device) Secondary endpoints: details revised at 4 of 6 entries · Primary endpoint revised · Study description shortened, about 3 wordsv12 Show 3 more changesShow less
    • Secondary endpoints: details revised at 4 of 6 entries
    • Primary endpoint revised
    • Study description shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

Show 10 earlier versionsHide 10 earlier versions
  1. Site details revised at 1 of 12 sitesv11
  2. Lead sponsor: Innovalve Bio Medical Ltd. to Edwards Lifesciences Primary completion date: Jul 1, 2025 to Jul 1, 2026 · Study sites: 5 to 12 · Completion date: Jul 1, 2030 to Jul 1, 2031 · 1 morev10 Show 4 more changesShow less
    • Primary completion date: Jul 1, 2025 to Jul 1, 2026
    • Study sites: 5 to 12
    • Completion date: Jul 1, 2030 to Jul 1, 2031
    • Secondary endpoints: details revised at 4 of 6 entries
  3. Phase: Phase 1 to Not applicable Enrollment target: 30 to 65 · Primary completion date: Sep 1, 2024 to Jul 1, 2025 · Completion date: Sep 1, 2028 to Jul 1, 2030 · 1 morev9 Show 4 more changesShow less
    • Enrollment target: 30 to 65
    • Primary completion date: Sep 1, 2024 to Jul 1, 2025
    • Completion date: Sep 1, 2028 to Jul 1, 2030
    • Site contacts updated at 5 of 5 sites
  4. Study sites: 4 to 5v8
  5. Primary completion date: Sep 1, 2023 to Sep 1, 2024v7
  6. Enrollment target: 15 to 30 Study sites: 3 to 4v6 Show 1 more changeShow less
    • Study sites: 3 to 4
  7. Study sites: 1 to 3v5
  8. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Eligibility criteria revisedv4 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  9. Primary completion date: Mar 15, 2022 to Sep 1, 2023 Start date: Sep 15, 2021 to Sep 1, 2022 · Completion date: Mar 15, 2027 to Sep 1, 2028v3 Show 2 more changesShow less
    • Start date: Sep 15, 2021 to Sep 1, 2022
    • Completion date: Mar 15, 2027 to Sep 1, 2028
  10. Study Status, Contacts/Locationsv2
  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.
Study to evaluate the safety and performance of the INNOVALVE system
Trial Details
NCT Number NCT04919980
Lead Sponsor Edwards Lifesciences
Conditions Mitral Valve Regurgitation (Degenerative or Functional)
Enrollment 85 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov