RecruitingNCT06620757

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

Enrollment

234 participants

Start Date

Oct 10, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study looks at the safety of using a shorter course of just one blood-thinning medication after a procedure to close off a small pouch in the heart (called the left atrial appendage) in people with an irregular heartbeat (atrial fibrillation). Normally, patients take two blood thinners after this procedure. Researchers want to see if just one is safer and equally effective. **You may be eligible if...** - You are 18 or older - You have atrial fibrillation (irregular heartbeat) not caused by a faulty heart valve - Your stroke risk score (CHA₂DS₂-VASc) is high enough (at least 2 for men, 3 for women) - You cannot take long-term blood thinners due to a medical reason - You successfully had a left atrial appendage closure device (LAmbre) placed without complications - You are willing and able to return for follow-up visits **You may NOT be eligible if...** - You are currently enrolled in another investigational drug study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSingle 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06620757


Related Trials