Clinical Trial

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

Study acronym: S-SAPT LAMBRE
Recruiting
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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.
Protocol Amendment History 17 amendments
This ClinicalTrials.gov record has been amended 17 times since 2024-09-27; most recent amendment 2025-07-03.
Status change: Not Yet Recruiting → Recruiting 2024-10-13
Trial Details
NCT Number NCT06620757
Lead Sponsor Fundación EPIC
Conditions Atrial Fibrillation
Enrollment 234 participants
Start Date 2024-10-10
Primary Completion 2026-10-01 (estimated)
Study Completion 2027-10-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-04