Stand-alone Left Atrial Appendage Occlusion for Thromboembolism Prevention (SALAMANDER)

Nicolaus Copernicus University

Status: Enrolling

Conditions: Atrial Fibrillation; Stroke

Treatments: Device: Percutaneous LAAO - WATCHMAN; Device: Totally thoracoscopic LAAO - ATRICLIP; Device: Hybrid- minimally invasive LAAO - LARIAT

Study type: Observational

Funder types: Other

Identifiers

NCT05144958

SALAMANDER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

400 participants in 3 patient groups

Totally thoracoscopic LAAO - ATRICLIP

Description:

In this group, LAA will be sealed using the epicardial thoracoscopic approach with the ATRICLIP device.

Treatment:

Device: Totally thoracoscopic LAAO - ATRICLIP

Percutaneous LAAO - WATCHMAN

Description:

In this population, LAA will be occluded using an endocardial totally-percutaneous approach with the WATCHMAN device.

Treatment:

Device: Percutaneous LAAO - WATCHMAN

Hybrid- minimally invasive LAAO - LARIAT

Description:

In these patients, LAA will be closed using a hybrid, combined endo- and epicardial approach using the LARIAT system.

Treatment:

Device: Hybrid- minimally invasive LAAO - LARIAT