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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
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
Conditions
Interventions
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