Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04482062 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

TRISCEND II Pivotal Trial

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

Record History

  1. Enrollment target: estimated 1070 to confirmed 864 Primary completion date changed from estimate of Dec 21, 2025 to Dec 5, 2025v26 Show 1 more changeShow less
    • Primary completion date changed from estimate of Dec 21, 2025 to Dec 5, 2025
  2. Completion date: Dec 31, 2029 to Jun 27, 2030v25
  3. Re-verified, no change to tracked fieldsv24
  4. Primary completion date: Jun 11, 2024 to Dec 21, 2025 Primary endpoints: 3 to 16 · Eligibility criteria expanded, about 674 words · Secondary endpoints: 1 to 45v23 Show 3 more changesShow less
    • Primary endpoints: 3 to 16
    • Eligibility criteria expanded, about 674 words
    • Secondary endpoints: 1 to 45

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv22
Show 20 earlier versionsHide 20 earlier versions
  1. Study sites revised (62)v21 See this version in full on ClinicalTrials.gov ↗
  2. Trial status: Recruiting to Active, Not Recruiting Study sites: 65 to 62v20 Show 1 more changeShow less
    • Study sites: 65 to 62
  3. Primary completion date changed from estimate of Jun 30, 2024 to Jun 11, 2024v19
  4. Site contacts updated at 1 of 65 sitesv18
  5. Site details revised at 1 of 65 sitesv17
  6. Enrollment target: 820 to 1070 Primary completion date: Jun 2024 to Jun 30, 2024 · Completion date: Jun 2028 to Dec 31, 2029 · Site details revised at 11 of 65 sites · 1 morev16 Show 4 more changesShow less
    • Primary completion date: Jun 2024 to Jun 30, 2024
    • Completion date: Jun 2028 to Dec 31, 2029
    • Site details revised at 11 of 65 sites
    • Study arms: 3 to 4
  7. Study sites: 58 to 65v15
  8. Study sites: 56 to 58v14
  9. Study sites: 54 to 56v13
  10. Study sites: 51 to 54 Eligibility criteria shortened, about 10 wordsv12 Show 1 more changeShow less
    • Eligibility criteria shortened, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites: 50 to 51v11
  12. Study sites: 49 to 50v10
  13. Enrollment target: 775 to 820 Study sites: 41 to 49v9 Show 1 more changeShow less
    • Study sites: 41 to 49
  14. Study sites: 32 to 41v8
  15. Study sites: 26 to 32v7
  16. Study sites: 25 to 26v6
  17. Study sites: 15 to 25v5
  18. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 675 to 775 · Study sites: 1 to 15 · Start date changed from estimate of Jan 2021 to Apr 9, 2021v4 Show 3 more changesShow less
    • Enrollment target: 675 to 775
    • Study sites: 1 to 15
    • Start date changed from estimate of Jan 2021 to Apr 9, 2021
  19. Start date: Oct 2020 to Jan 2021 Study sites: 0 to 1v3 Show 1 more changeShow less
    • Study sites: 0 to 1
  20. Lead sponsor: [Redacted] to Edwards Lifesciences Trial status: Withheld to Not Yet Recruiting · Primary completion date: Jun 2024 · Completion date: Jun 2028 · 2 morev2 Show 5 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary completion date: Jun 2024
    • Completion date: Jun 2028
    • Start date: Oct 2020
    • Study title shortened, 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.
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
Trial Details
NCT Number NCT04482062
Lead Sponsor Edwards Lifesciences
Conditions Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases, Cardiovascular Diseases, Heart Failure
Enrollment 864 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov