The GLACE Study: Evaluating CLAAS With ICE Guided LAA Closure

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial completed Show 4 more changesShow less
    • Final enrollment: 67 participants (planned 80)
    • Study completion date changed from estimate of Sep 22, 2026 to Sep 8, 2026
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 8 entries
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Dec 2025 to Nov 10, 2025
    • Study completion date: Dec 2025 to Sep 22, 2026
    • Site details revised at 4 of 4 sites
    v5
  3. Study sites: 3 to 4
    • Primary completion date: Jun 2025 to Dec 2025
    v4
  4. Study sites: 2 to 3v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Sep 30, 2024 to Sep 24, 2024
    v2
  6. Study First Submitted
  • 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 CLAAS® device will be evaluated for safety and performance in the reduction of stroke in subjects with non-valvular atrial fibrillation under intracardiac echocardiography (ICE) imaging for left atrial appendage closure.
Trial Details
NCT Number NCT06580275
Lead Sponsor Conformal Medical, Inc
Conditions
(from sponsor)		 Atrial Fibrillation, Stroke Prevention
Related terms Atrial Fibrillation, Stroke
Enrollment 67 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov