Clinical trial NCT05144958: Stand-alone Left Atrial Appendage Occlusion for Thromboembolism Prevention
Official title: Stand-Alone Left Atrial Appendage Occlusion for throMboembolism Prevention in Nonvalvular Atrial fibrillatioN DiseasE Registry (SALAMANDER)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Stroke
Lead sponsor: Nicolaus Copernicus University
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with non-valvular AF and high risk of thromboembolic and bleeding complications defined by CHA2DS2-VASc Score \> 2 and HAS-BLED score of \> 2 referred to stroke prevention who do not require an open chest surgery for other reasons.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety and efficacy
timeFrame: 30 days
Secondary outcomes:
measure: Long-term sequelae
timeFrame: 5 years
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Cardiac Surgery, Centre of Postgraduate Education
state: Mazovian
Study officials:
References:
citation: Kowalewski M, Wanha W, Litwinowicz R, Kolodziejczak M, Pasierski M, Januszek R, Kuzma L, Grygier M, Lesiak M, Kaplon-Cieslicka A, Reczuch K, Gil R, Pawlowski T, Bartus K, Dobrzycki S, Lorusso R, Bartus S, Deja MA, Smolka G, Wojakowski W, Suwalski P. Stand-Alone Left Atrial appendage occlusion for throMboembolism prevention in nonvalvular Atrial fibrillatioN DiseasE Registry (SALAMANDER): protocol for a prospective observational nationwide study. BMJ Open. 2022 Sep 21;12(9):e063990. doi: 10.1136/bmjopen-2022-063990.