Arrhythmias & electrophysiology
The left atrial appendage exclusion for prophylactic stroke reduction (LEAAPS) trial: Rationale and design
Study context
- Population
- Adults ≥18 years undergoing planned cardiac surgery, without pre-existing atrial fibrillation (AF) but at increased risk of AF and stroke (age, CHA2DS2-VASc score, left atrium size or brain natriuretic peptide)planned enrolment
- Participants
- 6,500 adults
- Planned comparison
- Left atrial appendage exclusion (LAAE) with AtriClip vs no LAAE during cardiac surgery
- Primary endpoint
- First occurrence of ischemic stroke, systemic arterial embolism, or surgical or endovascular LAA closure
Methodological detailsrationale and design, international, prospective, multicentre, blinded, 1:1 randomisation, 250 sites, Follow-up every 6 months for a minimum of 5 years, Patient and healthcare providers outside the operating room blinded to allocation, Powered secondary endpoint: ischemic stroke or systemic arterial embolism, Primary safety endpoint (through 30 days): pericardial effusion requiring percutaneous or surgical treatment, peri-operative major bleeding, deep sternal wound infection, or MI, Primary analysis when 469 patients have had an ischemic stroke or systemic embolism
- Rationale and design
- International
- Prospective
- Multicentre
- Blinded
- 1:1 randomisation
- 250 sites
- Follow-up every 6 months for a minimum of 5 years
- Patient and healthcare providers outside the operating room blinded to allocation
- Powered secondary endpoint: ischemic stroke or systemic arterial embolism
- Primary safety endpoint (through 30 days): pericardial effusion requiring percutaneous or surgical treatment, peri-operative major bleeding, deep sternal wound infection, or MI
- Primary analysis when 469 patients have had an ischemic stroke or systemic embolism
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
The left atrial appendage exclusion for prophylactic stroke reduction (LEAAPS) trial: Rationale and design. Am Heart J. Published 11 October 2024. doi:10.
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