Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 AtriClipĀ®. 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Included | The consecutive patients with atrial fibrillation assigned to totally thoracoscopic stand-alone left atrial appendage occlusion using AtriClipĀ® for stroke prevention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AtriClip⢠LAA Exclusion System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative complications | Number of perioperative complications associated with AtriClip placement | 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. | Intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac and cerebrovascular events (MACCE) | Number of Participants with combined end point of death, acute heart failure, myocardial infarction and stroke. | 5 years |
| Pulmonary complications. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Intra-Operative Exclusion Criteria
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piotr Suwalski, PhD | Contact | +48225081269 | suwalski.piotr@gmail.com | |
| Anna Witkowska, MD | Contact | +48662076716 | vera@rallywitkowscy.pl |
| Name | Affiliation | Role |
|---|---|---|
| Piotr Suwalski, PhD | Central Clinical Hospital of Ministry of the Interior and Administration in Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Clinical Hospital of Ministry of the Interior and Administration in Warsaw | Recruiting | Warsaw | 02-507 | Poland |
Not provided
Not provided
Not provided
Not provided
|
|
| Oral anticoagulation therapy | Drug | Anticoagulation therapy discontinuation - according to the standard of care at the discretion of the Investigator. |
|
Number of participants requiring prolonged mechanical ventilation postoperatively
| 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 | Up to 30 days post operation |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided