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NOT YET RECRUITING
NCT07260474
NA

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

Sponsor: Fundación EPIC

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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.