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ACTIVE NOT RECRUITING
NCT02321137
NA

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

Sponsor: University of Turku

View on ClinicalTrials.gov

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

PROCEDURE

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.

PROCEDURE

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