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Updated: Jun 10, 2025
Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
The left atrial appendage exclusion for prophylactic stroke reduction (LEAAPS) trial: Rationale and design
Richard P Whitlock1, Patrick M McCarthy2, Marc W Gerdisch3
1Department of Surgery, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada.
Insights
This study investigates Left Atrial Appendage Exclusion (LAAE) to prevent stroke in cardiac surgery patients without atrial fibrillation. The LeAAPS trial will determine if LAAE reduces stroke and embolism risk long-term.
Area of Science:
- Cardiology
- Neurology
- Vascular Surgery
Background:
- Left atrial appendage exclusion (LAAE) is proven to reduce ischemic stroke in patients with atrial fibrillation (AF) undergoing cardiac surgery.
- Many patients without pre-existing AF undergoing cardiac surgery are still at risk for stroke.
Purpose of the Study:
- To evaluate the effectiveness of LAAE in preventing ischemic stroke or systemic embolism in patients undergoing cardiac surgery who are at increased risk of AF and stroke.
- To assess the safety of LAAE during cardiac surgery.
Main Methods:
- The Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction (LeAAPS) trial is a prospective, randomized, multicenter, blinded study.
- 6500 patients at increased risk for stroke and AF (but without pre-existing AF) will be randomized 1:1 to receive LAAE with AtriClip or no LAAE during cardiac surgery.
- Follow-up is for a minimum of 5 years, with primary analysis upon 469 primary endpoint events.
Main Results:
- Primary effectiveness endpoint: first occurrence of ischemic stroke, systemic arterial embolism, or surgical/endovascular LAA closure.
- Powered secondary effectiveness endpoint: ischemic stroke or systemic arterial embolism.
- Primary safety endpoint includes pericardial effusion, major bleeding, deep sternal wound infection, or myocardial infarction within 30 days.
Conclusions:
- The LeAAPS trial will determine if LAAE with AtriClip during cardiac surgery reduces stroke or systemic embolism in high-risk patients without pre-existing AF.
- Results will inform prophylactic stroke reduction strategies in a broader surgical population.
Introduction:
Left atrial appendage exclusion (LAAE) has been shown in randomized trials to reduce ischemic stroke risk in patients undergoing cardiac surgery with known atrial fibrillation (AF). Many patients undergoing cardiac surgery without pre-existing AF are at risk of stroke and may benefit from LAAE.
Methods:
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction (LeAAPS) is an international, prospective, randomized, multicenter, blinded trial evaluating the effectiveness of LAAE in preventing ischemic stroke or systemic embolism in patients undergoing cardiac surgery at increased risk of AF and ischemic stroke. The trial will enroll 6500 patients at increased risk of stroke in whom a cardiac surgery is planned at 250 sites worldwide. Eligible patients are ≥18 years old, have no pre-existing AF but are at increased risk for AF and stroke (based on age, CHA2DS2-VASc score, left atrium size or brain natriuretic peptide). Patients are randomized 1:1 to receive either LAAE with AtriClip or no LAAE during cardiac surgery. Healthcare providers outside of the operating room and the patient will be blinded to allocation. The primary effectiveness endpoint is the first occurrence of ischemic stroke, systemic arterial embolism, or surgical or endovascular LAA closure. The powered secondary effectiveness endpoint is ischemic stroke or systemic arterial embolism. The primary safety endpoint is the occurrence of one of the following events (through 30 days): pericardial effusion requiring percutaneous or surgical treatment, peri-operative major bleeding, deep sternal wound infection, or myocardial infarction. Other endpoints include mortality, rehospitalizations, clinically diagnosed AF, transient ischemic attack, and cognitive and quality of life assessments. Follow-up is every 6 months for a minimum of 5 years; primary analysis occurs when 469 patients have had an ischemic stroke or systemic embolism.
Conclusion:
The results of the LeAAPS trial will demonstrate whether LAAE with AtriClip at the time of other routine cardiac surgery reduces stroke or systemic arterial embolism during long-term follow-up in patients at high risk of stroke without pre-existing AF.
Trial Registration:
ClinicalTrials.gov, Identifier: NCT05478304, https://clinicaltrials.gov/study/NCT05478304?term=%20NCT05478304&rank=1.
