Actively Recruiting
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
Led by Fundación EPIC · Updated on 2025-07-04
234
Participants Needed
22
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 18 years and over
- Documented nonvalvular atrial fibrillation without moderate or severe mitral stenosis or mechanical heart valve
- CHA2DS2-VASc score 2 (men) or 3 (women)
- Contraindication for long-term anticoagulant treatment
- Successful LAmbre Left Atrial Appendage Closure device implantation with no in-hospital complications
- Ability and willingness to return for follow-up visits and examinations
- Signed informed consent
You will not qualify if you...
- Currently enrolled in another investigational study except purely observational registries
- Need for long-term anticoagulation therapy for reasons other than AF-related stroke risk
- Allergic or contraindicated to both aspirin and clopidogrel
- Indication for chronic aspirin or clopidogrel treatment for other medical conditions
- Planned or recent cardiac or noncardiac intervention or surgery within 30 days before or 60 days after implant
- Stroke or transient ischemic attack within 30 days prior to enrollment
- Major bleeding event within 30 days prior to inclusion or unresolved bleeding
- Active bleeding
- Myocardial infarction within 30 days prior to enrollment
- History of atrial septal repair or presence of ASD/PFO device
- Childbearing potential or plans to become pregnant during the study
- Documented life expectancy less than one year
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 22 locations
1
Hospital Universitario A Coruña
A Coruña, Spain, 15006
Actively Recruiting
2
Hospital Clínico San Carlos
Aravaca, Spain, 28040
Actively Recruiting
3
Hospital Del Mar
Barcelona, Spain, 08003
Actively Recruiting
4
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Actively Recruiting
5
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 08035
Actively Recruiting
6
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
7
Hospital Universitario Reina Sofía de Córdoba
Córdoba, Spain, 14004
Actively Recruiting
8
Hospital Universitario La Paz
Fuencarral-El Pardo, Spain, 28046
Actively Recruiting
9
Hospital Universitario de Cabueñes
Gijón, Spain, 33394
Actively Recruiting
10
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Spain, 08907
Actively Recruiting
11
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Spain, 35010
Actively Recruiting
12
Hospital Universitario de Leon
León, Spain, 24008
Actively Recruiting
13
Hospital Universitari Arnau de Vilanova
Lleida, Spain, 25198
Actively Recruiting
14
Hospital Central de La Defensa Gómez Ulla
Madrid, Spain, 28047
Actively Recruiting
15
Hospital Universitario Puerta De Hierro
Majadahonda, Spain, 28222
Actively Recruiting
16
Hospital de Manises
Manises, Spain, 46940
Actively Recruiting
17
Hospital Regional Universitario de Málaga
Málaga, Spain, 29010
Actively Recruiting
18
Hospital Universitario Son Espases
Palma de Mallorca, Spain, 07120
Actively Recruiting
19
Hospital Clínico Universitario de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
20
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
21
Hospital Universitario de Tarragona Juan XXIII
Tarragona, Spain, 43005
Actively Recruiting
22
Hospital Universitario y Politécnico La Fe
Valencia, Spain, 46026
Actively Recruiting
Research Team
B
BEATRIZ VAQUERIZO, MD, PhD
CONTACT
F
FUNDACION EPIC
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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