Short-Term Anticoagulation versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure. The ANDES study.

Phase 4

Not yet recruiting

• Conditions: Atrial Fibrillation Device thrombosis post-Left Atrial Appendage Closure

• Registration Number: 2025-520954-12-00
• Lead Sponsor: Centre Hospitalier Universite De Laval

Brief Summary

To compare the incidence of device thrombosis following LAAC between patients receiving short-term (8 weeks) anticoagulation therapy (DOAC) vs. antiplatelet therapy

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-02-03
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

Patients undergoing successful LAAC with any approved device

Age≥18 years old

Exclusion Criteria

Absolute contraindications for AC therapy

Absolute contraindications for antiplatelet therapy

End-stage renal disease (CrCl <15 ml/min)

Recent percutaneous revascularization with drug-eluting stents necessitating dual antiplatelet therapy

Prior intracranial hemorrhage

Contraindications for TEE

Severe pericardial effusion within the first 24 hrs following LAAC

Major/life-threatening bleeding within the first 24 hrs following LAAC

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint: Device thrombosis as evaluated by TEE 60 days after LAAC and analyzed in a central echo core lab (as-treated analysis)		Primary Efficacy Endpoint: Device thrombosis as evaluated by TEE 60 days after LAAC and analyzed in a central echo core lab (as-treated analysis)
Primary Safety Endpoint :Adverse clinical events including all-cause mortality, stroke, bleeding, or device thrombosis* within 60 days after LAAC (intention-to-treat analysis) * As clinically evaluated and diagnosed by the center investigators and determining a treatment change		Primary Safety Endpoint :Adverse clinical events including all-cause mortality, stroke, bleeding, or device thrombosis* within 60 days after LAAC (intention-to-treat analysis) * As clinically evaluated and diagnosed by the center investigators and determining a treatment change

Secondary Outcome Measures

Name	Time	Method
Device thrombosis as evaluated by TEE or computed tomography 12 months after LAAC		Device thrombosis as evaluated by TEE or computed tomography 12 months after LAAC
Ischemic events (stroke, TIA) at 2-months and 1-, 2-, 3-, 4-, 5-year follow-up		Ischemic events (stroke, TIA) at 2-months and 1-, 2-, 3-, 4-, 5-year follow-up
Bleeding events at 2-months and 1-, 2-, 3-, 4-, 5-year follow-up		Bleeding events at 2-months and 1-, 2-, 3-, 4-, 5-year follow-up

Trial Locations

Locations (7)

Hospital Alvaro Cunqueiro; 🇪🇸 Vigo, Spain

Hospital Clinic De Barcelona; 🇪🇸 Barcelona, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Bellvitge University Hospital; 🇪🇸 L'Hospitalet De Llobregat, Spain

Instituto Bernabeu Palma De Mallorca S.L.; 🇪🇸 Palma, Spain

Hospital De La Santa Creu I Sant Pau; 🇪🇸 Barcelona, Spain

Area De Salud De Salamanca; 🇪🇸 Salamanca, Spain

Hospital Alvaro Cunqueiro

🇪🇸Vigo, Spain

Andres Iñiguez Romo

Site contact

986211111

andres.iniguez.romo@sergas.es