Stand-alone Left Atrial Appendage Occlusion for Thromboembolism Prevention

  • STATUS
    Recruiting
  • End date
    Mar 1, 2025
  • participants needed
    400
  • sponsor
    Nicolaus Copernicus University
Updated on 13 December 2021
anesthesia
electrocardiogram
stroke
vascular disease
thromboembolism
anticoagulation therapy
left atrial appendage occlusion

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.

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.

Details
Condition Atrial Fibrillation, Stroke
Treatment Totally thoracoscopic LAAO - ATRICLIP, Percutaneous LAAO - WATCHMAN, Hybrid- minimally invasive LAAO - LARIAT
Clinical Study IdentifierNCT05144958
SponsorNicolaus Copernicus University
Last Modified on13 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

patients aged ≥18 years
ECG/Holter diagnosis of AF
Previous stroke or systemic thromboembolic complications
High risk of thromboembolic complications - CHA2DS2-VASc Score ≥ 2
HASBLED score of > 2
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

No ECG with AF recorded (12-lead ECG, Holter recording, external event recorder or
implantable loop recorder) or only atrial flutter recorded
Significant valve disease or coronary multivessel artery lesions requiring operation
Stroke/cerebrovascular accident (CVA) within previous 30 days
Critical preoperative state
participation in a clinical trial
patient refusal
Registry imposes intraoperative exclusion criteria to otherwise enrolled patients
Presence of thrombus in the LA or LAA
LAA tissue with significant adhesions (as evaluated by the surgeon) making AtriClip®
placement overly risky
Previous cardiac operations (e.g., CABG, heart transplant, valvular replacement)
making LARIAT placement overly risky
NYHA IV
Patients with a previous atrial septal defect with surgical or transcatheter closure
Right-sided heart failure
making Watchman placement overly risky
Symptomatic carotid artery disease
active systemic infection
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