Multicentre, multinational, prospective, randomized, open, blinded end-point clinical trial.
Adults scheduled for open-heart surgery are included regardless of known atrial fibrillation, provided left atrium appendage (LAA) closure is not previously planned. Patients are stratified by site, surgery type and postoperative oral anticoagulation treatment, and subsequently be randomized 1:1 to either LAA closure in addition to planned open-heart surgery or standard care.
The primary endpoint is stroke or TIA occurring over at least two years following surgery. Secondary endpoints are: Total mortality and a combination of stroke, TIA or image of recent cerebral infarction in clinical settings demonstrated postoperatively, until the end follow-up.
To determine if Left Atrium Appendage (LAA) closure added to planned open heart surgery protects against post-operative major stroke and minor stroke.
Innovation Fund Denmark, Novo Nordisk Foundation, Ib Mogens Christiansen, and Bispebjerg-Frederiksberg Research Fund.