No phaseRecruiting
Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure (CALAMBRE)
Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure: the CALAMBRE Randomized Clinical Trial
- Sponsor
- Fundación EPIC (Academic or other)
- Enrolment
- 200 planned
- Conditions
- Coronary Artery Disease
- Interventions
- Patients implanted with Amplatzer Amulet™; Patients implanted with LAmbre™
- Ages
- adults, older adults
- Registry
- NCT07260474
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- EFFICACY: Device success
History
Study completion expected
Primary completion expected
Last registry update
Registered
Started