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SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation

Study acronym: SAPIEN M3 EFS
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial completed Study completion date changed from estimate of Aug 31, 2027 to Aug 20, 2026 · Eligibility criteria expanded, about 32 words · Site details revised at 2 of 9 sites Show 3 more changesShow less
    • Study completion date changed from estimate of Aug 31, 2027 to Aug 20, 2026
    • Eligibility criteria expanded, about 32 words
    • Site details revised at 2 of 9 sites
  2. Minor Completion date: Aug 2027 to Aug 31, 2027v15
  3. Minor Enrollment target: 74 to 72v14
  4. Minor 4 versions Re-verified since May 19, 2022, no change to tracked fieldsv10-v13
  5. Notable Lead sponsor: [Redacted] to Edwards Lifesciences Trial status: Withheld to Active, Not Recruiting · Primary completion date: Jun 16, 2021 · Completion date: Aug 2027 · 2 morev9 Show 5 more changesShow less
    • Trial status: Withheld to Active, Not Recruiting
    • Primary completion date: Jun 16, 2021
    • Completion date: Aug 2027
    • Start date: Sep 14, 2017
    • Study title expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  6. Minor 7 versions Re-verified since Aug 24, 2017, no change to tracked fieldsv2-v8
  7. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System.
Trial Details
NCT Number NCT03230747
Lead Sponsor Edwards Lifesciences
Conditions Mitral Regurgitation, Mitral Disease
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov