Arrhythmias & electrophysiology
The left atrial appendage closure by surgery-2 (LAACS-2) trial protocol rationale and design of a randomized multicenter trial investigating if left atrial appendage closure prevents stroke in patients undergoing open-heart surgery irrespective of preoperative atrial fibrillation status and stroke risk
Study context
- Population
- Adults ≥18 years scheduled for first-time planned open-heart surgery in Denmark, Spain and Sweden, with or without prior atrial fibrillation (AF), irrespective of CHA2DS2-VASc scoreplanned
- Participants
- 1,500 adults
- Planned comparison
- Concomitant left atrial appendage (LAA) closure vs standard care during open-heart surgery
- Primary endpoint
- Stroke, including TIA, adjudicated by 2 independent blinded neurologists
- Follow-up
- 2 years
Methodological detailsprotocol, multicentre, stratified randomisation, 1:1, blinded outcome assessment, Sample size powered (90%, significance level 0.05) to detect a 60% relative risk reduction in the primary outcome
- Protocol
- Multicentre
- Stratified randomisation
- 1:1
- Blinded outcome assessment
- Sample size powered (90%, significance level 0.05) to detect a 60% relative risk reduction in the primary outcome
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
The left atrial appendage closure by surgery-2 (LAACS-2) trial protocol rationale and design of a randomized multicenter trial investigating if left atrial appendage closure prevents stroke in patients undergoing open-heart surgery irrespective of preoperative atrial fibrillation status and stroke risk. Am Heart J. Published 10 June 2023. doi:10.
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