- Question
- Does percutaneous left atrial appendage ligation added to pulmonary vein isolation improve catheter ablation outcomes for nonparoxysmal atrial fibrillation compared with pulmonary vein isolation alone?
- Design
- Multicenter, prospective, open-label, randomized (2:1) clinical trial using a bayesian adaptive analysis for the primary end points. Patients were enrolled at 53 US sites from October 2015 to December 2019, with follow-up of 12 months after pulmonary vein isolation.
- Population
- Patients with nonparoxysmal atrial fibrillation present for less than 3 years, scheduled for pulmonary vein isolation.
- Intervention
- Percutaneous left atrial appendage ligation with the LARIAT system followed by catheter pulmonary vein isolation. 404 patients were randomized to this group.
- Control
- Catheter pulmonary vein isolation alone (206 patients).
- Primary outcome
- Effectiveness: freedom from documented atrial arrhythmias lasting more than 30 seconds at 12 months after pulmonary vein isolation (Holter monitoring at 6 and 12 months, symptomatic event monitoring, or any electrocardiographic tracing). Safety: a composite of predefined serious adverse events at 30 days, compared with a prespecified 10% performance goal.
- Results
- Freedom from arrhythmia at 12 months was 64.3% with ligation plus pulmonary vein isolation and 59.9% with isolation alone (difference 4.3%; bayesian 95% credible interval -4.2% to 13.2%; posterior superiority probability 0.835), which did not meet the statistical criterion for superiority (0.977). At 12 months, complete appendage closure (0 mm residual communication) was seen in 84% of patients.
- Safety
- The primary safety end point was met: the 30-day serious adverse event rate was 3.4% (bayesian 95% credible interval 2.0% to 5.0%), below the prespecified 10% threshold.
- Conclusion
- Left atrial appendage ligation added to pulmonary vein isolation did not meet prespecified efficacy criteria versus isolation alone, but met safety criteria and achieved high closure rates.
- Why it matters
- It tested in a randomized trial the idea that eliminating the appendage would improve ablation outcomes, and it did not show a benefit supporting routine use for that purpose in nonparoxysmal atrial fibrillation.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026