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Peer-reviewedCC BY 4.0Frontiers in Cardiovascular Medicine

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

  • Xinyu Xu1
  • Yunfan Li1
  • Fengmin Lu2
  • Huanming Li3
  • Heng Cai4
4 affiliations
  1. 1School of Biomedical Engineering and Technology, Tianjin Medical University
  2. 2Department of Cardiology, Tianjin Chest Hospital
  3. 3Department of Cardiology, Tianjin 4th Central Hospital
  4. 4Department of Cardiology, Tianjin Medical University General Hospital
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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.

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Cite

BibTeXRIS
BibTeX
@article{xu2026asymmetric,
  title = {{Asymmetric biphasic pulsed field ablation of paroxysmal atrial fibrillation: clinical assessment}},
  author = {Xinyu Xu and Yunfan Li and Fengmin Lu and Huanming Li and Heng Cai},
  journal = {Frontiers in Cardiovascular Medicine},
  year = {2026},
  month = oct,
  doi = {10.3389/fcvm.2026.1945178},
  url = {https://www.frontiersin.org/articles/10.3389/fcvm.2026.1945178/full},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Asymmetric biphasic pulsed field ablation of paroxysmal atrial fibrillation: clinical assessment
AU  - Xinyu Xu
AU  - Yunfan Li
AU  - Fengmin Lu
AU  - Huanming Li
AU  - Heng Cai
PY  - 2026
DA  - 2026/10/16
JO  - Frontiers in Cardiovascular Medicine
DO  - 10.3389/fcvm.2026.1945178
UR  - https://www.frontiersin.org/articles/10.3389/fcvm.2026.1945178/full
AB  - 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.
SN  - 2297-055X
ER  -