Clinical Trial

Left Atrial Appendage CLOSURE for the Prevention of Thromboembolisms in Patients Undergoing Aortic Bioprosthesis Surgery

Study acronym: LAA-CLOSURE
Active, Not Recruiting
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Summary
The primary purpose of the LAA-CLOSURE trial is to assess the efficacy and safety of surgical closure of LAA in patients undergoing aortic valve replacement. This randomized, prospective, open-label international multicenter trial will enroll 1040 patients undergoing aortic valve replacement with CHA2DS2-VASC score ≥2 but without an indication for anticoagulation at the time of enrollment. Patients will be randomized in 1:1 fashion to standard therapy + surgical closure of LAA vs. standard therapy alone. The duration of the study is five years (plus additional 10 years).
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2014-12-16; most recent amendment 2025-06-05.
Status change: Recruiting → Active, Not Recruiting 2025-06-05
Trial Details
NCT Number NCT02321137
Lead Sponsor University of Turku
Collaborators: Helsinki University Central Hospital, Kuopio University Hospital, St. Antonius Hospital, Landspitali University Hospital
Conditions Aortic Stenosis
Enrollment 1,040 participants
Start Date 2014-11
Primary Completion 2025-04-30 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2025-06-10