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

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

Detailed Description
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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.

Official Title
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Stand-Alone Thoracoscopic Epicardial Left Atrial Appendage Occlusion With AtriClip® Device for Thromboembolism Prevention in Nonvalvular Atrial Fibrillation - the Polish Nationwide Registry.

Conditions
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Stroke Prevention, Atrial Fibrillation, Safety Issues

Intervention / Treatment
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* Device: AtriClip™ LAA Exclusion System
* Drug: Oral anticoagulation therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Included<br>The consecutive patients with atrial fibrillation assigned to totally thoracoscopic stand-alone left atrial appendage occlusion using AtriClip® for stroke prevention. | Device: AtriClip™ LAA Exclusion System<br>* The left atrial appendage is closed from the epicardial side of the heart. Operative access is totally thoracoscopic. The designed and dedicated clip - AtriClip® (AtriCure, Ohio, USA) is introduced to the left pleura through thoracoscopic port.<br>* Other names: AtriClip LAA Exclusion System and Delivery System (PRO2);Drug: Oral anticoagulation therapy<br>* Anticoagulation therapy discontinuation - according to the standard of care at the discretion of the Investigator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative complications | Number of perioperative complications associated with AtriClip placement | First 5 postoperative days | 
| Intraoperative success of exclusion of LAA. | Successful exclusion of LAA is defined as no communication between LAA and LA and < 5 mm LAA remnant measured by intraoperative transesophageal echo with Doppler. | Intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac and cerebrovascular events (MACCE) | Number of Participants with combined end point of death, acute heart failure, myocardial infarction and stroke. | 5 years | 
| Pulmonary complications. | Number of participants requiring prolonged mechanical ventilation postoperatively | Up to 30 days post operation | 
| Any complications connected with surgical intervention | Rate of bleeding requiring transfusion or re-operation, phrenic nerve palsy, oedema requiring intervention, wound infection, abscess in pleura | Up to 30 days post operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LAAO, Stroke prevention, Atrial fibrillation, Totally thoracoscopic, AtriClip®