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2019-06 TRISCEND Study

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. 3 versions Re-verified since Aug 13, 2025, no change to tracked fieldsv21-v23
  2. Study sites: 22 to 20v20
  3. Results first posted: Jan 9, 2025 Primary endpoints: 1 to 5 · Secondary endpoints: 5 to 10 · Publications: 1 to 2v19 Show 3 more changesShow less
    • Primary endpoints: 1 to 5
    • Secondary endpoints: 5 to 10
    • Publications: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 200 to confirmed 228 · Study sites: 25 to 22 · Primary completion date changed from estimate of Oct 31, 2025 to Jan 5, 2024 · 1 morev18 Show 4 more changesShow less
    • Enrollment target: estimated 200 to confirmed 228
    • Study sites: 25 to 22
    • Primary completion date changed from estimate of Oct 31, 2025 to Jan 5, 2024
    • Completion date: Dec 31, 2025 to Jan 31, 2029
  5. Site details revised at 2 of 25 sitesv17
Show 15 earlier versionsHide 15 earlier versions
  1. Site details revised at 1 of 25 sitesv16
  2. Primary completion date: Oct 2025 to Oct 31, 2025 Completion date: Dec 2025 to Dec 31, 2025 · Study description revised · Site details revised at 4 of 25 sites · 1 morev15 Show 4 more changesShow less
    • Completion date: Dec 2025 to Dec 31, 2025
    • Study description revised
    • Site details revised at 4 of 25 sites
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 18 of 25 sitesv14
  4. Study sites: 24 to 25v13
  5. Primary endpoint revised Study sites: 20 to 24 · Eligibility criteria expanded, about 7 wordsv12 Show 2 more changesShow less
    • Study sites: 20 to 24
    • Eligibility criteria expanded, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 17 to 20v11
  7. Study sites: 16 to 17v10
  8. Enrollment target: 75 to 200 Study sites: 12 to 16v9 Show 1 more changeShow less
    • Study sites: 12 to 16
  9. Study sites: 11 to 12v8
  10. Study sites: 9 to 11v7
  11. Enrollment target: 45 to 75v6
  12. Enrollment target: 15 to 45 Study sites: 7 to 9v5 Show 1 more changeShow less
    • Study sites: 7 to 9
  13. Study sites: 6 to 7v4
  14. Lead sponsor: [Redacted] to Edwards Lifesciences Trial status: Withheld to Recruiting · Primary completion date: Oct 2025 · Completion date: Dec 2025 · 3 morev3 Show 6 more changesShow less
    • Trial status: Withheld to Recruiting
    • Primary completion date: Oct 2025
    • Completion date: Dec 2025
    • Start date: May 6, 2020
    • Study sites expanded, about 22 words
    • Study title shortened, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  15. Lead sponsor: Edwards Lifesciences to [Redacted] Trial status: Not Yet Recruiting to Withheld · Primary completion date: Oct 2025 to not stated · Completion date: Dec 2025 to not stated · 2 morev2 Show 5 more changesShow less
    • Trial status: Not Yet Recruiting to Withheld
    • Primary completion date: Oct 2025 to not stated
    • Completion date: Dec 2025 to not stated
    • Start date: May 2020 to not stated
    • Study title expanded, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  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.
Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System
Trial Details
NCT Number NCT04221490
Lead Sponsor Edwards Lifesciences
Conditions Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
Enrollment 228 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov