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COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 25 to 27v24
  2. Re-verified, no change to tracked fieldsv23
  3. Study sites: 24 to 25v22
  4. Study sites: 21 to 24v21
  5. Study sites: 19 to 21v20
Show 18 earlier versionsHide 18 earlier versions
  1. Study sites: 18 to 19v19
  2. Study sites: 16 to 18v18
  3. Study sites: 14 to 16v17
  4. Study sites: 12 to 14 Interventions: SAPIEN 3 THV (Drug), SAPIEN 3/SAPIEN 3 Ultra RESILIA THV (Device) to SAPIEN 3 THV (Device), SAPIEN 3 Ultra RESILIA THV (Device), SAPIEN 3/SAPIEN 3 Ultra RESILIA THV (Device) · Secondary endpoints: 9 to 10v16 Show 2 more changesShow less
    • Interventions: SAPIEN 3 THV (Drug), SAPIEN 3/SAPIEN 3 Ultra RESILIA THV (Device) to SAPIEN 3 THV (Device), SAPIEN 3 Ultra RESILIA THV (Device), SAPIEN 3/SAPIEN 3 Ultra RESILIA THV (Device)
    • Secondary endpoints: 9 to 10

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Jul 2023 to Dec 2026 Completion date: Dec 2027 to Jun 2031 · Interventions: SAPIEN 3 THV (Device) to SAPIEN 3 THV (Drug), SAPIEN 3/SAPIEN 3 Ultra RESILIA THV (Device) · Site details revised at 1 of 12 sites · 3 morev15 Show 6 more changesShow less
    • Completion date: Dec 2027 to Jun 2031
    • Interventions: SAPIEN 3 THV (Device) to SAPIEN 3 THV (Drug), SAPIEN 3/SAPIEN 3 Ultra RESILIA THV (Device)
    • Site details revised at 1 of 12 sites
    • Publications: details revised at 1 of 2 entries
    • Study arms: 2 to 3
    • Eligibility criteria shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  6. Primary completion date: Jan 2023 to Jul 2023v14
  7. Study sites revised (12)v13 See this version in full on ClinicalTrials.gov ↗
  8. Primary endpoint revised Eligibility criteria expanded, about 176 words · Secondary endpoints: 1 to 9 · Study description shortened, about 54 words · 1 morev12 Show 4 more changesShow less
    • Eligibility criteria expanded, about 176 words
    • Secondary endpoints: 1 to 9
    • Study description shortened, about 54 words
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  9. Enrollment target: 58 to 108 Primary completion date: Jul 17, 2018 to Jan 2023 · Completion date: Dec 2022 to Dec 2027 · Study description expanded, about 13 wordsv11 Show 3 more changesShow less
    • Primary completion date: Jul 17, 2018 to Jan 2023
    • Completion date: Dec 2022 to Dec 2027
    • Study description expanded, about 13 words

    See this version in full on ClinicalTrials.gov ↗

  10. Trial status: Active, Not Recruiting to Recruiting Primary completion date changed from estimate of Aug 2019 to Jul 17, 2018 · Site details revised at 12 of 12 sitesv10 Show 2 more changesShow less
    • Primary completion date changed from estimate of Aug 2019 to Jul 17, 2018
    • Site details revised at 12 of 12 sites
  11. Primary completion date: Apr 2018 to Aug 2019 Trial status: Recruiting to Active, Not Recruiting · Study sites: 14 to 12v9 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 14 to 12
  12. Primary endpoint revised Primary completion date: Mar 2018 to Apr 2018 · Eligibility criteria shortened, about 32 words · Study description expanded, about 8 wordsv8 Show 3 more changesShow less
    • Primary completion date: Mar 2018 to Apr 2018
    • Eligibility criteria shortened, about 32 words
    • Study description expanded, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  13. Phase: Phase 3 to Not applicable Start date: Apr 2016 to Jul 5, 2016 · Study sites: 11 to 14v7 Show 2 more changesShow less
    • Start date: Apr 2016 to Jul 5, 2016
    • Study sites: 11 to 14
  14. Primary completion date: Dec 2017 to Mar 2018v6
  15. Primary endpoint revisedv5 See this version in full on ClinicalTrials.gov ↗
  16. Study sites: 2 to 11 Eligibility criteria shortened, about 146 words · Secondary endpoints: 10 to 1 · Study title expanded, about 3 wordsv4 Show 3 more changesShow less
    • Eligibility criteria shortened, about 146 words
    • Secondary endpoints: 10 to 1
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  17. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 2v3 Show 1 more changeShow less
    • Study sites: 1 to 2
  18. Study sites: 0 to 1v2
  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.
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.
Trial Details
NCT Number NCT02744677
Lead Sponsor Edwards Lifesciences
Conditions Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
Enrollment 108 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov