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Left Atrial Appendage CLOSURE for the Prevention of Thromboembolisms in Patients Undergoing Aortic Bioprosthesis Surgery
Sponsor: University of Turku
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).
Official title: A Randomized Prospective Multicenter Trial for Stroke Prevention by Surgical Occlusion of the Left Atrial Appendage in Patients Undergoing Aortic Bioprosthetic Surgery
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1040
Start Date
2014-11
Completion Date
2029-12
Last Updated
2025-06-10
Healthy Volunteers
No
Conditions
Interventions
Surgical closure of left atrial appendage
aortic valve replacement with bioprosthesis according to indications in the current guidelines for the management of valvular heart disease. The operation as well as the pre and post-operative care will be performed according to local surgical policies.
No closure of left atrial appendage
aortic valve replacement with bioprosthesis according to indications in the current guidelines for the management of valvular heart disease.
Locations (4)
Helsinki University Hospital
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
Turku University Hospital
Turku, Finland
St Antonius Hospital
Utrecht, Netherlands