Clinical Trial

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

Study acronym: CALAMBRE
Not Yet Recruiting
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Summary
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 2026-01-30
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-01-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-03