Stand-alone Left Atrial Appendage Occlusion for Thromboembolism Prevention — SALAMANDER  

Stroke Clinical Trial

Official title: Stand-Alone Left Atrial Appendage Occlusion for throMboembolism Prevention in Nonvalvular Atrial fibrillatioN DiseasE Registry (SALAMANDER)

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke
• Thromboembolism

• NCT number: NCT05144958
• Study type: Observational [Patient Registry]
• Source: Nicolaus Copernicus University
• Contact: Mariusz Kowalewski, MD, PhD
• Phone: 502269240
• Email: kowalewskimariusz@gazeta.pl
• Status: Recruiting
• Start date: March 1, 2019
• Completion date: March 1, 2025