Pulsed Field Ablation for Ventricular Arrhythmias

Starting soon · Not applicable

Conditions studied: Ventricular Arrhythmias

In brief

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.

Key facts

Study ID

NCT07727330

Run by

Xi'an Jiaotong University

People needed

30

Starts

2026-07-01

Expected to finish

2028-04-01

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Frequent premature ventricular contractions, defined as a premature ventricular contraction burden greater than 10% of total heartbeats on 24-hour Holter monitoring;
• Sustained monomorphic ventricular tachycardia;
• History of malignant ventricular arrhythmias, including sustained polymorphic ventricular tachycardia, ventricular flutter, or ventricular fibrillation, with an indication for catheter ablation.
• 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.

You may not qualify if…

• Presence of atrial arrhythmias before the procedure that cannot be treated using the study device.
• Ventricular arrhythmias caused by electrolyte disturbance, reversible causes, or non-cardiac causes.
• Severe left ventricular enlargement, defined as left ventricular anteroposterior diameter greater than 80 mm.
• Left ventricular ejection fraction of 35% or less.
• New York Heart Association functional class III or IV.
• Previous cardiac surgery, including patent foramen ovale closure, left atrial appendage closure, cardiac valve repair or replacement, or other cardiac surgery that makes the participant unsuitable for catheter ablation.
• Significant congenital cardiac anatomical abnormalities that prevent the ablation catheter from accessing the target ablation area.
• Planned cardiac surgery or other major surgery within the next 12 months that may affect ablation treatment, including heart transplantation, left atrial appendage closure, or patent foramen ovale closure.
• Intracardiac thrombus, myxoma, occlusion device, or other condition that may interfere with catheter insertion or manipulation.
• Severe vascular access obstruction, such as an implanted inferior vena cava filter or mural thrombus.
• Uncontrolled hypertension, defined as persistent systolic blood pressure of 180 mmHg or higher or persistent diastolic blood pressure of 110 mmHg or higher.
• Severe restrictive or obstructive pulmonary disease or chronic respiratory disease that, in the investigator's judgment, makes the participant unsuitable for cardiac intervention.
• Obvious bleeding tendency or hematologic disease.
• Untreated or uncontrolled hyperthyroidism or hypothyroidism.
• Acute or severe systemic active infection, significant hepatic or renal dysfunction defined as ALT, AST, or creatinine greater than twice the upper limit of normal, malignancy, or end-stage disease.
• Unstable angina or acute myocardial infarction within 3 months before enrollment.
• Percutaneous coronary intervention or coronary artery bypass grafting within 3 months before enrollment.
• Stroke or transient ischemic attack within 3 months before enrollment.
• Thromboembolic disease.
• Clear contraindication to interventional procedures or ablation as determined by the investigator.
• Pregnancy, lactation, or planned pregnancy during the study period.
• Participation in another drug or medical device clinical trial within 3 months before enrollment.
• Any condition that, in the investigator's judgment, makes the participant unsuitable for participation in this clinical study.

Full record on ClinicalTrials.gov

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