Clinical trial NCT03838341: Stand-alone Totally Thoracoscopic Left Atrial Appendage Occlusion Using AtriClip® Device in Non-valvular Atrial Fibrillation.
Official title: Stand-Alone Thoracoscopic Epicardial Left Atrial Appendage Occlusion With AtriClip® Device for Thromboembolism Prevention in Nonvalvular Atrial Fibrillation - the Polish Nationwide Registry.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke Prevention
Atrial Fibrillation
Safety Issues
Keywords: Stroke prevention
Atrial fibrillation
Totally thoracoscopic
LAAO
AtriClip®
Lead sponsor: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The registry will include all patients with atrial fibrillation with high risk of thromboembolic complications - CHA2DS2-VASc Score \>2 and HASBLED score of =\> 2 refered to primary or secondary stroke prevention who do not require open chest surgery for other reasons.

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Perioperative complications
timeFrame: First 5 postoperative days
measure: Intraoperative success of exclusion of LAA.
timeFrame: Intraoperatively
Secondary outcomes:
measure: Major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: 5 years
measure: Pulmonary complications.
timeFrame: Up to 30 days post operation
measure: Any complications connected with surgical intervention
timeFrame: Up to 30 days post operation
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Central Clinical Hospital of Ministry of the Interior and Administration in Warsaw
Study officials:
affiliation: Central Clinical Hospital of Ministry of the Interior and Administration in Warsaw
name: Piotr Suwalski, PhD
role: PRINCIPAL_INVESTIGATOR
References: