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Beating Heart Mitral Valve Repair With the HARPOON™ System

Study acronym: RESTORE
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. 2 versions Re-verified since Aug 25, 2025, no change to tracked fieldsv24-v25
  2. Primary completion date: Oct 20, 2023 to Dec 20, 2027 Primary endpoints: 2 to 1 · Study sites: 31 to 9 · Completion date: Dec 2027 to Dec 20, 2027 · 1 morev23 Show 4 more changesShow less
    • Primary endpoints: 2 to 1
    • Study sites: 31 to 9
    • Completion date: Dec 2027 to Dec 20, 2027
    • Secondary endpoints shortened, about 36 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date changed from estimate of Dec 2023 to Oct 20, 2023v22
  4. Enrollment target: estimated 360 to confirmed 25 Trial status: Recruiting to Active, Not Recruiting · Study sites: 32 to 31v21 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 32 to 31
  5. Study sites: 30 to 32v20
Show 18 earlier versionsHide 18 earlier versions
  1. Study sites: 28 to 30v19
  2. Study sites: 27 to 28v18
  3. Study sites: 26 to 27 Eligibility criteria expanded, about 2 wordsv17 Show 1 more changeShow less
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 25 to 26v16
  5. Study sites: 23 to 25v15
  6. Study sites: 21 to 23v14
  7. Study sites: 20 to 21v13
  8. Study sites: 17 to 20v12
  9. Study sites: 14 to 17 Eligibility criteria expanded, about 24 words · Secondary endpoints expanded, about 36 wordsv11 Show 2 more changesShow less
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints expanded, about 36 words

    See this version in full on ClinicalTrials.gov ↗

  10. Study sites: 12 to 14v10
  11. Study sites: 11 to 12v9
  12. Study sites: 8 to 11v8
  13. Study sites revised (8)v7 See this version in full on ClinicalTrials.gov ↗
  14. Study sites: 4 to 8 Start date changed from estimate of Dec 2020 to Dec 16, 2020v6 Show 1 more changeShow less
    • Start date changed from estimate of Dec 2020 to Dec 16, 2020
  15. Start date: Oct 2020 to Dec 2020v5
  16. Re-verified, no change to tracked fieldsv4
  17. Lead sponsor: [Redacted] to Edwards Lifesciences Trial status: Withheld to Recruiting · Primary completion date: Dec 2023 · Completion date: Dec 2027 · 2 morev3 Show 5 more changesShow less
    • Trial status: Withheld to Recruiting
    • Primary completion date: Dec 2023
    • Completion date: Dec 2027
    • Start date: Oct 2020
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  18. Re-verified, no change to tracked fieldsv2
  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.
The objective of the study is to evaluate the safety and effectiveness of the HARPOON™ System in the treatment of patients with severe degenerative mitral regurgitation (DMR).
Trial Details
NCT Number NCT04375332
Lead Sponsor Edwards Lifesciences
Conditions Mitral Regurgitation
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov