Work

Asymmetric biphasic pulsed field ablation of paroxysmal atrial fibrillation: clinical assessment

Year: 2026

Type: article

Abstract: Background: Pulsed field ablation (PFA) is a non-thermal, tissue-selective therapy for atrial fibrillation. In this study, we evaluated the safety and efficacy of a novel asymmetric biphasic PFA system, which combines a unique pulse-parameter configuration with a dedicated, adjustable six-spline catheter. Methods: This prospective, multicenter, single-arm study was conducted in China. Patients with drug-refractory paroxysmal AF underwent pulmonary vein isolation (PVI) using a 1,000 V asymmetric biphasic PFA system with a novel parameter configuration. The primary effectiveness endpoint was freedom from atrial arrhythmia recurrence through 12 months post-blanking. The primary safety endpoint was predefined serious adverse events. The secondary safety endpoint was hemolysis and silent cerebral lesions (SCLs). Results: Among 120 enrolled patients, 105 underwent ablation and completed the 12-month follow-up, while 15 patients withdrew before the PFA operation. Acute PVI was successfully achieved in all 420 targeted veins. At 12 months, the Kaplan-Meier estimate of freedom from atrial arrhythmia recurrence was 69.5% (95% CI, 60.1-77.5%). The observed 12-month effectiveness was within the range reported in previous studies of PFA technologies. Regarding safety, major procedural complications-including pulmonary vein stenosis, phrenic nerve injury, atrioesophageal fistula, stroke, and acute kidney injury (AKI)-were entirely absent. However, one patient (0.95%) experienced a transient coronary vasospasm that was successfully resolved with an intracoronary vasodilator. Additionally, SCLs were detected in two patients (1.9%). While laboratory hemolysis was a common finding, it did not lead to renal impairment. Conclusions: This asymmetric biphasic PFA system achieved complete acute PVI and 12-month effectiveness was within the range reported in previous studies of PFA technologies. It showed a favorable safety profile, with few SCLs and no hemolysis-related AKI. Clinical Trial Registration: https://www.chictr.org.cn/showproj.html?proj=134973, identifier ChiCTR2200062157.

Source: Frontiers in Cardiovascular Medicine

DOI: 10.3389/fcvm.2026.1945178

Authors: Xinyu Xu, Yunfan Li, Fengmin Lu, Huanming Li, Heng Cai

Institutions: Tianjin Medical University, Tianjin Chest Hospital, Tianjin Fourth Central Hospital, Tianjin Medical University General Hospital

Language: English

Topic: Atrial Fibrillation Management and Outcomes

Subfield: Cardiology and Cardiovascular Medicine

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,801