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Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure

Study acronym: CALAMBRE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Study sites: 0 to 1 · Start date changed from estimate of Jan 30, 2026 to May 5, 2024 · Eligibility criteria expanded, about 12 words · 2 more Show 5 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 30, 2026 to May 5, 2024
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 2 of 7 entries
    • Publications: details revised at 5 of 5 entries
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Clinical investigation with CE-marked medical devices, multicenter, prospective, randomized and controlled. Patients with non-valvular atrial fibrillation at high embolic risk and with at least one high bleeding risk criterion according to the Munich consensus document will be randomized to left atrial appendage closure with either the Amplatzer Amulet™ or the LAmbre™ device. The study is designed to compare the efficacy and safety of both devices regarding successful implantation, effective appendage closure, and clinical outcomes at follow-up.
Trial Details
NCT Number NCT07260474
Lead Sponsor Fundación EPIC
Conditions Coronary Artery Disease
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov