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Surgical Ablation of AF Efficacy Trial

Study acronym: SAFE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Sep 30, 2026 → Sep 30, 2027
See other at-risk trials from Population Health Research Institute

Record History

  1. Primary completion pushed from Sep 30, 2026 to Sep 30, 2027 Completion pushed from Dec 31, 2026 to Dec 31, 2027 · Eligibility criteria expanded, about 14 words · Secondary endpoints: details revised at 1 of 12 entries Show 3 more changesShow less
    • Completion pushed from Dec 31, 2026 to Dec 31, 2027
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 1 of 12 entries
  2. Re-verified, no change to tracked fieldsv6
  3. Eligibility criteria shortened, about 58 words Study description expanded, about 3 wordsv5 Show 1 more changeShow less
    • Study description expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of May 1, 2023 to Jun 1, 2023 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of May 1, 2023 to Jun 1, 2023
    • Site details revised
  5. Start date: Mar 1, 2023 to May 1, 2023v3
  6. Start date: Sep 1, 2022 to Mar 1, 2023v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
SAFE is an international multicentre RCT of concomitant surgical atrial fibrillation (AF) ablation in patients with paroxysmal or persistent AF undergoing cardiac surgery.
Trial Details
NCT Number NCT05434819
Lead Sponsor Population Health Research Institute
Collaborators: Hamilton Health Sciences Corporation
Conditions Atrial Fibrillation, Heart Failure
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov