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NOT YET RECRUITING
NCT07705282
NA

Standalone Thoracoscopic Left Atrial Appendage Closure Versus Medical Therapy in Atrial Fibrillation

Sponsor: Region Skane

View on ClinicalTrials.gov

Summary

Surgical left atrial appendage closure (LAAC) has been associated with reduced rates of stroke in patients with atrial fibrillation (AF) who have undergone cardiac surgery. In recent time, procedures with catheter-based devices for LAAC have failed to achieve results that would make them considered a safe alternative to oral anticoagulation. Several concerns regarding catheter-based devices have been raised due to their contact with circulating blood, device migration and periprocedural complications. LAAC using an externally placed clip via thoracoscopy would elude some of these concerns and may therefore be a feasible alternative to oral anticoagulation in patients with AF. This study aims to assess whether thoracoscopic left atrial appendage closure (TLAAC) is noninferior to medical treatment in patients with AF and an elevated bleeding risk using or being planned to initiate OAC and in those patients with clinical contraindications to oral anticoagulants.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

936

Start Date

2028-01-01

Completion Date

2032-12-31

Last Updated

2026-07-15

Healthy Volunteers

No

Interventions

PROCEDURE

Video-assisted thoracoscopic closure of the left atrial appendage using a closure device and discontinuation of treatment if the patient is treated with OAC

Video-assisted thoracoscopic closure of the left atrial appendage using a closure device and discontinuation of treatment if the patient is treated with OAC. If indicated due to co-morbidities, patients will be prescribed platelet inhibitors instead.

Locations (1)

Skånes universitetssjukhus

Lund, Sweden