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

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.

Inclusion Criteria: 1. Age ≥ 18 years and any of criteria 2-3 2. AF with a CHA2DS2-VA score ≥2 and a HAS-BLED score ≥3 or other clinically significant bleeding condition and ongoing OAC treatment 3. AF with a CHA2DS2-VA score ≥2 but deemed unfit for OAC by responsible physician due to clinical contraindications (e.g. amyloid angiopathy, previous intracranial haemorrhage or severe gastrointestinal bleeding). Exclusion Criteria: 1. Clinical frailty score ≥5 2. Indication for OAC other than AF 3. Indication for dual antiplatelet therapy, if OAC is discontinued 4. Previous open-heart surgery 5. Present indication for cardiac surgery 6. Present indication for ablation for atrial fibrillation 7. Previous radiation therapy of the chest, due to malignancy 8. Previous pericarditis or myocarditis 9. Previous surgery including access to the left pleural space 10. Documented FEV1\