Stand-alone Left Atrial Appendage Occlusion for Thromboembolism Prevention

Recruiting

• Conditions: Atrial Fibrillation; Stroke
• Interventions: Device: Percutaneous LAAO - WATCHMAN; Device: Hybrid- minimally invasive LAAO - LARIAT; Device: Totally thoracoscopic LAAO - ATRICLIP

• Registration Number: NCT05144958
• Lead Sponsor: Nicolaus Copernicus University

Brief Summary

This prospective nationwide registry aims to assess the durability of left atrial appendage occlusion when performed via totally thoracoscopic, percutaneous and hybrid- minimally invasive approaches and collect information on possible adverse events.

Detailed Description

Stand-Alone Left Atrial appendage occlusion for throMboembolism prevention in Nonvalvular Atrial Fibrillation DiseasE Registry (SALAMANDER) will commence in 37 heart surgery centers across Poland and has no limit of patient recruitment. Included in the registry will be all \>18 y.o. patients with AF and high risk of thromboembolic and bleeding complications defined by CHA2DS2-VASc Score \> 2 and HASBLED score of \> 2 referred to stroke prevention who do not require an open chest surgery for other reasons. The primary outcome will be the number of perioperative (in-hospital/30-days) complications associated with LAA closure device placement and intraoperative success of exclusion of LAA as assessed by transesophageal echocardiography. Secondary outcomes will be major adverse cardiac and cerebrovascular events (MACCE, combined endpoint of death, acute heart failure, myocardial infarction and stroke); pulmonary complications and any complications connected with surgical intervention. AF-related risks, including stroke/systemic thromboembolism and bleeding outcomes, will be assessed. Medical history, risk factors, demographic information and management will be collected at baseline, and clinical events during 1 -year follow-up will be recorded. Follow-up will be conducted for at least 1 year and then annually thereafter till year 5th post-op.

Study Timeline

• Study Start: 2019-03-01
• Status Verified: 2021-11
• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-11-22
• Last Update Submitted: 2021-11-22
• Study First Posted: 2021-12-06
• Last Update Posted: 2021-12-06
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. patients aged ≥18 years;
2. ECG/Holter diagnosis of AF;
3. Previous stroke or systemic thromboembolic complications;
4. High risk of thromboembolic complications - CHA2DS2-VASc Score ≥ 2;
5. HASBLED score of > 2;
6. Contraindications to oral anticoagulation or Complications of oral anticoagulation;

(8) Acceptable surgical candidate, including use of general anesthesia; (9) patient adherence to the study and patient Informed Consent Form has been signed

Exclusion Criteria

1. No ECG with AF recorded (12-lead ECG, Holter recording, external event recorder or implantable loop recorder) or only atrial flutter recorded,
2. Significant valve disease or coronary multivessel artery lesions requiring operation;
3. Stroke/cerebrovascular accident (CVA) within previous 30 days;
4. Critical preoperative state;
5. participation in a clinical trial
6. patient refusal

Registry imposes intraoperative exclusion criteria to otherwise enrolled patients:

1. Presence of thrombus in the LA or LAA
2. LAA tissue with significant adhesions (as evaluated by the surgeon) making AtriClip® placement overly risky.
3. Previous cardiac operations (e.g., CABG, heart transplant, valvular replacement) making LARIAT placement overly risky.
4. Patients with a previous atrial septal defect with surgical or transcatheter closure making Watchman placement overly risky.
5. NYHA IV;
6. Right-sided heart failure;
7. Symptomatic carotid artery disease;
8. active systemic infection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Percutaneous LAAO - WATCHMAN	Percutaneous LAAO - WATCHMAN	In this population, LAA will be occluded using an endocardial totally-percutaneous approach with the WATCHMAN device.
Hybrid- minimally invasive LAAO - LARIAT	Hybrid- minimally invasive LAAO - LARIAT	In these patients, LAA will be closed using a hybrid, combined endo- and epicardial approach using the LARIAT system.
Totally thoracoscopic LAAO - ATRICLIP	Totally thoracoscopic LAAO - ATRICLIP	In this group, LAA will be sealed using the epicardial thoracoscopic approach with the ATRICLIP device.

Primary Outcome Measures

Name	Time	Method
Safety and efficacy	30 days	The number of peri-operative (in-hospital/30-days) complications associated with LAA closure device placement and intraoperative success of exclusion of LAA as assessed by transesophageal echocardiography

Secondary Outcome Measures

Name	Time	Method
Long-term sequelae	5 years	Major adverse cardiac and cerebrovascular events (MACCE, combined endpoint of death, acute heart failure, myocardial infarction and stroke); pulmonary complications and any complications connected with surgical intervention.

Trial Locations

Locations (1)

Department of Cardiac Surgery, Centre of Postgraduate Education; 🇵🇱 Warsaw, Mazovian, Poland