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Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure
Sponsor: Fundación EPIC
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.
Official title: Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure: the CALAMBRE Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-01-30
Completion Date
2027-01-31
Last Updated
2025-12-03
Healthy Volunteers
No
Conditions
Interventions
Patients implanted with Amplatzer Amulet™
Left atrial appendage closure with the Amplatzer Amulet™ device. The procedure will be performed according to standard practice using the manufacturer's instructions for use.
Patients implanted with LAmbre™
Left atrial appendage closure with the LAmbre™ device. The procedure will be performed according to standard practice using the manufacturer's instructions for use.