12-Month Clinical Outcomes Using a Variable-Loop Circular Catheter for PFA in a Chinese Atrial Fibrillation Population.
Hailong Tao, Heng Cai, Hua Fu et al.
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In 30 seconds
The afIRE study was a prospective, multicenter, single-arm clinical trial of variable-loop circular catheter pulsed field ablation in Chinese adults with symptomatic, drug-refractory paroxysmal atrial fibrillation undergoing first-time pulmonary vein isolation. In the 123-patient main-stage cohort, 12-month primary effectiveness success was 74.8%, while freedom from symptomatic recurrence was 87.0%. Acute pulmonary vein isolation was achieved in all patients. Primary adverse events occurred in 2 patients (1.6%), both involving vascular complications and considered unlikely to be device-related.
Key findings
- At 12 months, primary effectiveness success was 74.8%; freedom from symptomatic recurrence was 87.0%.
- Acute pulmonary vein isolation was achieved in all patients; 89.4% had no acute reconnection.
- Primary adverse events occurred in 2 patients (1.6%); both were vascular complications considered unlikely to be device-related.
- Preserved left ventricular ejection fraction (≥ 60%) was associated with 86% reduction in odds of 12-month atrial arrhythmia recurrence.
Why it matters
These results add prospective evidence on pulsed field ablation with a variable-loop catheter in a Chinese population, where evidence had been limited. The reported effectiveness and low incidence of primary adverse events provide useful context for assessing whether outcomes observed in European and US studies are reproducible across populations, while the single-arm design limits comparative conclusions.
What to keep in mind
The study was single-arm, so it cannot establish comparative effectiveness or safety against another ablation approach.