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

Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland100 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Stroke Prevention Atrial Fibrillation Safety Issues

Interventions

AtriClip™ LAA Exclusion SystemDEVICE

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.

Oral anticoagulation therapyDRUG

Anticoagulation therapy discontinuation - according to the standard of care at the discretion of the Investigator.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Central Clinical Hospital of Ministry of the Interior and Administration in Warsaw

Warsaw, Poland

RECRUITING

Outcomes

Primary Outcomes

Perioperative complications

Number of perioperative complications associated with AtriClip placement

Time frame: 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.

Time frame: Intraoperatively

Secondary Outcomes

Major adverse cardiac and cerebrovascular events (MACCE)

Number of Participants with combined end point of death, acute heart failure, myocardial infarction and stroke.

Time frame: 5 years

Pulmonary complications.

Number of participants requiring prolonged mechanical ventilation postoperatively

Time frame: 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

Time frame: Up to 30 days post operation

Central Contacts

Piotr Suwalski, PhD

CONTACT

+48225081269 suwalski.piotr@gmail.com

Anna Witkowska, MD

CONTACT

+48662076716 vera@rallywitkowscy.pl

Data from ClinicalTrials.gov

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