Stand-alone Totally Thoracoscopic Left Atrial Appendage Occlusion Using AtriClip® Device in Non-valvular Atrial Fibrillation.

Atrial Fibrillation Clinical Trial

— THORACS-LAAO  

Official title:

Stand-Alone Thoracoscopic Epicardial Left Atrial Appendage Occlusion With AtriClip® Device for Thromboembolism Prevention in Nonvalvular Atrial Fibrillation - the Polish Nationwide Registry.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03838341
• Other study ID #: ThR-LAAO-PL
• Status: Recruiting
• Start date: June 8, 2015
• Est. completion date: January 1, 2025

Study information

• Verified date: March 2019
• Source: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
• Contact: Piotr Suwalski, PhD
• Phone: +48225081269
• Email: suwalski.piotr[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2025
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Safety Issues
• Stroke Prevention

Intervention

Device:
• 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.

Drug:
• Oral anticoagulation therapy
Anticoagulation therapy discontinuation - according to the standard of care at the discretion of the Investigator.

Locations

Country	Name	City	State
Poland	Central Clinical Hospital of Ministry of the Interior and Administration in Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative complications	Number of perioperative complications associated with AtriClip placement	First 5 postoperative days
Primary	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
Secondary	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
Secondary	Pulmonary complications.	Number of participants requiring prolonged mechanical ventilation postoperatively	Up to 30 days post operation
Secondary	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