Arrhythmias & electrophysiologyRandomised controlled trial
Pulmonary Vein Isolation With or Without Left Atrial Appendage Ligation in Atrial Fibrillation
- Randomised controlled trial
- multicentre
- prospective
- open-label
- 2:1 randomisation
- bayesian adaptive analysis
Authors' conclusion
Percutaneous left atrial appendage ligation adjunctive to pulmonary vein isolation did not meet prespecified efficacy criteria for freedom from atrial arrhythmias at 12 months compared with pulmonary vein isolation alone for patients with nonparoxysmal atrial fibrillation, but met prespecified safety criteria and demonstrated high rates of closure at 12 months.
Study context
- Population
- Nonparoxysmal AF present <3 years, planned PVI; 53 US sites, 2015–2019
- Comparison
- LAA ligation plus PVI vs PVI alone
- Primary endpoint
- Freedom from documented atrial arrhythmias >30 seconds (primary effectiveness)
- Follow-up
- 12 months after PVI
Primary result
Freedom from atrial arrhythmias · 12 months
Difference
4.3%
95% CrI −4.2% to 13.2%
By group
As reported in the abstract
Further findings
| Outcome | Values |
|---|---|
| LAA closure (LAA ligation + PVI) · 12 months | LAA ligation + PVI Complete closure (0 mm residual communication) 84% · ≤5 mm residual communication 99% |
Safety
Primary safety: composite of predefined serious AEs vs prespecified 10% performance goal · 30 days after the procedure
- 30-day serious adverse event rate (primary safety met; < prespecified threshold of 10%)
- 3.4%
- bayesian 95% CrI 2.0% to 5.0%
- posterior probability 1.0
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Summarised from the published abstract; every number is checked against it