This is a prospective, single-center, single-arm exploratory clinical study designed to evaluate the efficacy and safety of pulsed field ablation for the treatment of ventricular arrhythmias.
Approximately 30 patients with ventricular arrhythmias who have an indication for catheter ablation and are scheduled to undergo pulsed field ablation will be enrolled. Eligible participants may include patients with frequent premature ventricular contractions, sustained monomorphic ventricular tachycardia, or a history of malignant ventricular arrhythmias with an indication for catheter ablation.
All participants will undergo pulsed field ablation using a disposable magnetic navigation and contact force-sensing pulsed field ablation catheter. The study will assess immediate procedural success, treatment success at 6 months after ablation, procedural characteristics, quality of life, and adverse events or serious adverse events during the study period.
Inclusion Criteria:
Participants must meet all of the following criteria:
Age 18 to 75 years, inclusive.
Diagnosis of ventricular arrhythmia with an indication for catheter ablation, and scheduled to undergo pulsed field ablation, meeting one of the following conditions:
For participants with an indication for implantable cardioverter-defibrillator implantation, the participant has already received an implantable cardioverter-defibrillator or agrees to undergo implantable cardioverter-defibrillator implantation in the near future.
Able and willing to provide written informed consent and comply with all study follow-up requirements.
Exclusion Criteria:
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Participants with ventricular arrhythmias who meet the eligibility criteria will undergo pulsed field ablation using a disposable magnetic navigation and contact force-sensing pulsed field ablation catheter. The ablation target site, ablation strategy, and procedural endpoint will be determined by the investigator according to the type and origin of the ventricular arrhythmia, electroanatomical mapping findings, and standard clinical practice.
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