Left Atrium Appendage Closure by Surgery-2 (LAACS-2)
Study design
Multicentre, multinational, prospective, randomized, open, blinded end-point clinical trial.
About the project
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.
Objective(s)
To determine if Left Atrium Appendage (LAA) closure added to planned open heart surgery protects against post-operative major stroke and minor stroke.
Project group
- Helena Domínguez (Sponsor) & Christoffer Valdorff Madsen, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark
- Christian Lildal Carranza, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark
- Ivy Susanne Modrau, Aarhus University Hospital, Aarhus, Denmark
- Rafael Rodríguez Lecoq, Hospital Vall d’Hebron, Barcelona, Spain
- Anders Jeppsson, Sahlgrenska University Hospital, Gothenborg, Sweden
- Akhmadjon Irmukhamedov, Odense University Hospital, Odense, Denmark
Funding
Innovation Fund Denmark, Novo Nordisk Foundation, Ib Mogens Christiansen, and Bispebjerg-Frederiksberg Research Fund.
Published papers
- Dominguez H., Madsen C. V., Irmukhamedov A., Carranza C. L., Rafiq S., Rodriguez-Lecoq R., Torrents A., Moya-Mitjans A., Sharma V., Kruuse C. R., Nilsson B., Dixen U., Sajadieh A., Greve A. M., Park-Hansen J. The left atrial appendage closure by surgery-2 randomized trial. European Heart Journal. DOI: 10.1093/eurheartj/ehz745.0583
- Park-Hansen J., Holme S. J. V., Irmukhamedov A., Carranza C. L., Greve A. M., Al-Farra G., Riis R. G. C., Nilsson B., Clausen J. S. R., Nørskov A. S., Kruuse C. R., Rostrup E., Dominguez H. Adding left atrial appendage closure to open heart surgery provides protection from ischemic brain injury six years after surgery independently of atrial fibrillation history: the LAACS randomized study. J Cardiothorac Surg. DOI: 10.1186/s13019-018-0740-7
Status
Inclusion ongoing
Project period
Start: 1 Juni 2020
End: 1 December 2024
