Status:
UNKNOWN
Stand-alone Totally Thoracoscopic Left Atrial Appendage Occlusion Using AtriClip® Device in Non-valvular Atrial Fibrillation.
Lead Sponsor:
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Conditions:
Stroke Prevention
Atrial Fibrillation
Eligibility:
All Genders
18+ years
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) ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 8 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03838341
Start Date
June 8 2015
End Date
January 1 2025
Last Update
March 5 2019
Active Locations (1)
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1
Central Clinical Hospital of Ministry of the Interior and Administration in Warsaw
Warsaw, Poland, 02-507