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Ensaio clínico

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

NCT: NCT07260474 · RECRUITING

ID NCTNCT07260474
EstadoRECRUITING
Data de início2024-05-05
Conclusão2027-01-31
SponsorFundación EPIC (OTHER)
First posted
Last updated

Resumo breve

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.

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