Atrial Fibrillation, Safety Issues, Stroke Prevention
Conditions
Keywords
Stroke prevention, Atrial fibrillation, Totally thoracoscopic, LAAO, AtriClip®
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.
Interventions
DEVICEAtriClip™ 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.
Anticoagulation therapy discontinuation - according to the standard of care at the discretion of the Investigator.
Sponsors
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative complications | First 5 postoperative days | Number of perioperative complications associated with AtriClip placement |
| Intraoperative success of exclusion of LAA. | Intraoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac and cerebrovascular events (MACCE) | 5 years | Number of Participants with combined end point of death, acute heart failure, myocardial infarction and stroke. |
| Pulmonary complications. | Up to 30 days post operation | Number of participants requiring prolonged mechanical ventilation postoperatively |
| Any complications connected with surgical intervention | Up to 30 days post operation | Rate of bleeding requiring transfusion or re-operation, phrenic nerve palsy, oedema requiring intervention, wound infection, abscess in pleura |
Countries
Poland
Contacts
Primary ContactPiotr Suwalski, PhD
Backup ContactAnna Witkowska, MD
Outcome results
None listed