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RECRUITING
NCT06620757

Safety and Effectiveness of Short-Term Single AntiPlatelet Therapy After Left Atrial Appendage Closure With the LAmbre Device in Patients With Nonvalvular Atrial Fibrillation: A Multinational Real-world Registry

Sponsor: Fundación EPIC

View on ClinicalTrials.gov

Summary

Brief Summary: A prospective, multicenter, single-arm, non-randomized study including consecutive patients with nonvalvular AF(Atrial Fibrillation), with a CHA2DS2-VASc score ≥2 (men) or ≥3 (women), and contraindication for long-term anticoagulant treatment, with successful LAAC (Left Atrial Appendage Closure)procedure with the LAmbre device, who at discharge are eligible for short-term (3-months-only) SAPT. We want to assess if a short-term single antiplatelet therapeutic regime of Acetylsalicylic acid (ASA) 100 mg (or clopidogrel 75 mg if ASA contraindication), once daily, for 3 months is safe and effective at 12 months follow-up.

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

OBSERVATIONAL

Enrollment

234

Start Date

2024-10-10

Completion Date

2027-10-01

Last Updated

2025-07-04

Healthy Volunteers

No

Interventions

DRUG

Single antiplatelet therapy (SAPT)

Observational study of effectiveness and safety of SAPT (either with acetyl-salycilic acid or clopidogrel) after LAAO with Lambre device in patients with high risk of bleeding

Locations (22)

Hospital Universitario A Coruña

A Coruña, Spain

Hospital Clínico San Carlos

Aravaca, Spain

Hospital Del Mar

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitari Vall D'Hebron

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitario Reina Sofía de Córdoba

Córdoba, Spain

Hospital Universitario La Paz

Fuencarral-El Pardo, Spain

Hospital Universitario de Cabueñes

Gijón, Spain

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Spain

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Spain

Hospital Universitario de Leon

León, Spain

Hospital Universitari Arnau de Vilanova

Lleida, Spain

Hospital Central de La Defensa Gómez Ulla

Madrid, Spain

Hospital Universitario Puerta De Hierro

Majadahonda, Spain

Hospital de Manises

Manises, Spain

Hospital Regional Universitario de Málaga

Málaga, Spain

Hospital Universitario Son Espases

Palma de Mallorca, Spain

Hospital Clínico Universitario de Salamanca

Salamanca, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

Hospital Universitario de Tarragona Juan XXIII

Tarragona, Spain

Hospital Universitario y Politécnico La Fe

Valencia, Spain