Clinical Trial

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

Study acronym: STELLA-AF
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07705282
Lead Sponsor Region Skane
Conditions ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Oral Anticoagulation, Thoracotomy
Enrollment 936 participants
Start Date 2028-01-01
Primary Completion 2031-12-31 (estimated)
Study Completion 2032-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-15