Stand-alone Totally Thoracoscopic Left Atrial Appendage Occlusion Using AtriClip® Device in Non-valvular Atrial Fibrillation.
NCT ID: NCT03838341
Last Updated: 2019-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2015-06-08
2025-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Included
The consecutive patients with atrial fibrillation assigned to totally thoracoscopic stand-alone left atrial appendage occlusion using AtriClip® for stroke prevention.
AtriClip™ LAA Exclusion System
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 therapy
Anticoagulation therapy discontinuation - according to the standard of care at the discretion of the Investigator.
Interventions
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AtriClip™ LAA Exclusion System
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 therapy
Anticoagulation therapy discontinuation - according to the standard of care at the discretion of the Investigator.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Significant valve disease or coronary multi-vessel artery lesions requiring surgery
* Stroke/cerebrovascular accident (CVA) within previous 30 days
* Critical preoperative state
* 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.
18 Years
ALL
No
Sponsors
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Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
OTHER
Responsible Party
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Piotr Suwalski, PhD
Doctor of Philosophy
Principal Investigators
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Piotr Suwalski, PhD
Role: PRINCIPAL_INVESTIGATOR
Central Clinical Hospital of Ministry of the Interior and Administration in Warsaw
Locations
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Central Clinical Hospital of Ministry of the Interior and Administration in Warsaw
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ThR-LAAO-PL
Identifier Type: -
Identifier Source: org_study_id
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