Stand-alone Totally Thoracoscopic Left Atrial Appendage Occlusion Using AtriClip® Device in Non-valvular Atrial Fibrillation. (THORACS-LAAO)

Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

Status: Enrolling

Conditions: Atrial Fibrillation; Stroke Prevention; Safety Issues

Treatments: Drug: Oral anticoagulation therapy; Device: AtriClip™ LAA Exclusion System

Study type: Observational

Funder types: Other

Identifiers

NCT03838341

ThR-LAAO-PL

Details and patient eligibility

About

Polish multicenter registry to assess safety and durability of totally thoracoscopic left atrial appendage occlusion for stroke prevention in atrial fibrillation.

Full description

The THORACS-LAAO Registry is the Polish multi-institutional registry of the consecutive patients with atrial fibrillation assigned for the totally thoracoscopic left atrial appendage occlusion (LAAO) for stroke prevention with designed epicardial clip AtriClip®. The registry has no limit of the number of patient included. Patients will be followed up with transoesophageal echocardiography at 6-12 months to assess the durability of left atrial appendage (LAA) oclusion and collect the informations about possible adverse events.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 years
• Lone atrial fibrillation
• Previous stroke or systemic thromboembolic complications
• High risk of thromboembolic complications assessed with CHA2DS2-VASc Score >2
• High bleeding risk assessed with HASBLED score => 2.
• Contraindications to oral anticoagulation
• Complications of the oral anticoagulation
• Acceptable surgical candidate, including use of general anaesthesia

Exclusion criteria

• Patient refusal
• Significant valve disease or coronary multi-vessel artery lesions requiring surgery
• Stroke/cerebrovascular accident (CVA) within previous 30 days
• Critical preoperative state

Intra-Operative Exclusion Criteria

• Presence of thrombus in the left atrium or LAA as documented on intra-operative transesophageal echocardiography
• LAA tissue with significant adhesions (as evaluated by the surgeon) carries AtriClip placement overly risky.

Trial design

100 participants in 1 patient group

Included

Description:

The consecutive patients with atrial fibrillation assigned to totally thoracoscopic stand-alone left atrial appendage occlusion using AtriClip® for stroke prevention.

Treatment:

Device: AtriClip™ LAA Exclusion System

Drug: Oral anticoagulation therapy