Safety and feasibility of a balloon-based pulsed field ablation system for the catheter ablation of paroxysmal atrial fibrillation

Q: What is the clinical evidence from this study?

Population: Paroxysmal atrial fibrillation (n=56). Intervention: Balloon-based pulsed field ablation (PFA) system. Primary outcome: 6-month freedom from documented atrial arrhythmias.

Q: What does this research mean for the field?

A balloon-based pulsed field ablation system is safe and effective for pulmonary vein isolation in patients with paroxysmal atrial fibrillation, achieving a 100% acute success rate and 92.9% freedom from atrial arrhythmias at 6 months. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Peize Wang; Kun Zhang; Jinlong Bai; Xiuhong Dong; Shuai Yang; Lichao Tian; Zhaoqian Zhang; Zhi Li; Yuhao Miao; Jingjing Liu

doi:10.1007/s10840-026-02417-4

August 19, 2026Journal of Interventional Cardiac ElectrophysiologyOpen Access

Safety and feasibility of a balloon-based pulsed field ablation system for the catheter ablation of paroxysmal atrial fibrillation

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Key result

Balloon-based PFA achieves ~93% freedom from atrial arrhythmias at six months with low adverse events.

n=56

Why the study?

Pulsed field ablation is increasingly used for PVI in AF patients, but the safety and effectiveness of a balloon-based PFA system required assessment at 6 months after treatment.

Does a balloon-based pulsed field ablation system safely and effectively achieve pulmonary vein isolation and prevent recurrence in patients with paroxysmal atrial fibrillation?

Key Points

To assess the safety, acute procedural success, and 6-month effectiveness of a novel balloon-based pulsed field ablation system for pulmonary vein isolation in patients with paroxysmal atrial fibrillation.
Prospective, single-center, premarket study enrolled 56 patients (aged 18–75 years) with drug-refractory paroxysmal atrial fibrillation between November 2024 and September 2025 at TEDA International Cardiovascular Hospital in China.
Pulmonary vein isolation was performed under general anesthesia using a multi-electrode balloon catheter delivering bipolar, biphasic pulsed electric fields (±750 V) across antral and ostial positions.
Primary endpoints included primary serious adverse events, acute pulmonary vein isolation confirmed by bidirectional block, and freedom from documented atrial arrhythmias at 6 months following a 90-day blanking period.
Acute procedural effectiveness was achieved in 100% of targeted pulmonary veins (231/231) and 100% of patients (56/56), requiring an average of 33 ± 5.5 pulsed field ablation applications per patient.
Total procedure, fluoroscopy, and ablation times averaged 89.0 ± 30.7 minutes, 24.2 ± 8.3 minutes, and 20.0 ± 12.0 minutes, respectively.
The rate of freedom from documented atrial arrhythmias was 92.9% at 6 months; one primary serious adverse event occurred (1.8%, 1/56; transesophageal echocardiography-induced gastrointestinal bleeding), and one patient experienced cerebral infarction on postoperative Day 28.

Structured PICO

Does a balloon-based pulsed field ablation system safely and effectively achieve pulmonary vein isolation and prevent recurrence in patients with paroxysmal atrial fibrillation?

P

Population

56 patients aged 18-75 years with drug-refractory paroxysmal atrial fibrillation underwent pulmonary vein isolation using a balloon-based PFA system and were followed for 6 months.

I

Intervention

Pulmonary vein isolation (PVI) using a balloon-based pulsed field ablation (PFA) system (EnChannel Medical) delivering bipolar biphasic pulsed electric fields (± 750 V, 4 pulse trains per application).

O

Outcome

Rate of primary serious adverse events within 7 days, acute procedural effectiveness (pulmonary vein isolation), and 6-month freedom from clinically significant AF recurrence (documented AF, atrial flutter, or atrial arrhythmia lasting >30 s).

A novel balloon-based pulsed field ablation system demonstrated 100% acute pulmonary vein isolation success and 92.9% freedom from atrial arrhythmias at 6 months with a low complication rate in patients with paroxysmal atrial fibrillation.

Limitations

Small sample size of 56 patients limits evaluation of rare complications
Short 6-month follow-up period requires long-term validation
No electrophysiological remapping during follow-up; reliance on noninvasive ECG monitoring may underestimate recurrence
Single-center exploratory design limits generalizability
Small sample size (n=56) limiting the evaluation of rare complications
Short follow-up period (6 months) limiting the assessment of chronic efficacy and long-term complications
Lack of electrophysiological remapping during follow-up, relying only on noninvasive electrocardiographic monitoring for recurrence

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Implication

Single-center balloon PFA data suggest procedural feasibility; leaves open durability, safety, and generalizability pending larger trials.

Abstract

AIMS: Pulsed field ablation (PFA) is a ablation modality that is increasingly used for pulmonary vein isolation (PVI) in atrial fibrillation (AF) patients. This study assessed the safety and effectiveness of a balloon-based PFA system at 6 months after treatment. METHODS AND RESULTS: This study is a prospective, single-center, premarket study. A total of 56 patients with drug-refractory paroxysmal atrial fibrillation (PAF) were enrolled between November 2024 and September 2025 and underwent PVI with a balloon-based PFA system. The study endpoints were the rate of primary serious adverse events, acute procedural effectiveness and 6-month freedom from recurrence. Acute effectiveness was achieved in 100% (231/231) of the treated PVs (100% of patients, 56/56), with 33 ± 5.5 PFA applications/patient. The procedure, fluoroscopy, and transpired ablation times were 89.0 ± 30.7, 24.2 ± 8.3, and 20.0 ± 12.0 min, respectively. One (1.8%; 1/56) primary serious adverse event occurred: one patient developed intraoperative gastrointestinal bleeding due to TEE-induced mechanical injury. One patient developed a cerebral infarction on postoperative Day 28. The rate of freedom from documented atrial arrhythmias was 92.9% through 6 months after the index procedure. CONCLUSION: The primary results of this study demonstrate the safety and effectiveness of the balloon-based PFA system for performing PVI in patients with PAF.

Discussion

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Cite This Study

Wang et al. (2026) studied Paroxysmal atrial fibrillation (n=56). Balloon-based pulsed field ablation (PFA) system was evaluated on 6-month freedom from documented atrial arrhythmias. The balloon-based pulsed field ablation system achieved a 100% acute pulmonary vein isolation success rate and 92.9% freedom from atrial arrhythmias at 6 months, with a 1.8% serious adverse event rate.

synapsesocial.com/papers/6a895e96ca7ade938187c9a7 https://doi.org/10.1007/s10840-026-02417-4

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Safety and feasibility of a balloon-based pulsed field ablation system for the catheter ablation of paroxysmal atrial fibrillation

Key Points

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Safety and feasibility of a balloon-based pulsed field ablation system for the catheter ablation of paroxysmal atrial fibrillation

Key Points

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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