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Evaluation of the Efficacy and Safety of a Disposable Magnetic-Electrical Navigation CF-Sensing Pulsed Field Ablation Catheter and Cardiac Pulsed Field Ablation Generator for the Treatment of Drug-Refractory Symptomatic Idiopathic Outflow Tract Ventricular Arrhythmias

Evaluation of the Efficacy and Safety of a Disposable Magnetic-Electrical Navigation CF-Sensing Pulsed Field Ablation Catheter and Cardiac Pulsed Field Ablation Generator for the Treatment of Drug-Refractory Symptomatic Idiopathic Outflow Tract Ventricular Arrhythmias

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105647
Enrollment
Unknown
Registered
2025-07-08
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Arrhythmia

Interventions

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 80 years; 2. Symptomatic premature ventricular complexes (PVCs) originating from the outflow tract (with >10,000 PVCs documented on a 24-hour Holter monitor), or symptomatic ventricular tachycardia (VT) originating from the outflow tract, and scheduled for catheter ablation; 3. Refractory or intolerant to at least one anti-arrhythmic drug; 4. Willing to participate in the study, comply with the follow-up requirements of the protocol, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Previous failure of catheter ablation for ventricular arrhythmia or recurrence after the procedure; 2. History of ventricular flutter or ventricular fibrillation; 3. Presence of other concurrent ventricular arrhythmias; 4. Presence of supraventricular arrhythmias requiring anti-arrhythmic drug therapy; 5. Diagnosed with long QT syndrome or Brugada syndrome; 6. Presence of hypertrophic cardiomyopathy, dilated cardiomyopathy, ischemic cardiomyopathy, arrhythmogenic cardiomyopathy, rheumatic heart disease, or congenital heart disease; 7. Presence of intracardiac thrombus or diagnosed with cardiac myxoma; 8. New York Heart Association (NYHA) functional class III or IV, or left ventricular ejection fraction (LVEF) 2.5 times the upper limit of normal; 12. Preoperative alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal; 13. Preoperative serum creatinine > 2 times the upper limit of normal or undergoing dialysis; 14. Preoperative systolic blood pressure >= 180 mmHg and/or diastolic blood pressure >= 110 mmHg; 15. Patients with diabetes and preoperative HbA1c >= 9%; 16. History of cardiac surgeries including patent foramen ovale (PFO) closure, left atrial appendage (LAA) closure, valve repair/replacement, or other cardiac surgeries that render catheter ablation unsuitable; 17. Unstable angina or acute myocardial infarction within the past 3 months; 18. Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the past 3 months; 19. Malignancy or end-stage disease with life expectancy less than 12 months; 20. Pregnant or lactating women, or women planning to become pregnant during the study period; 21. Patients with psychiatric disorders or a history of mental illness who are unable to comply voluntarily; 22. Currently participating in another interventional clinical trial; 23. Deemed unsuitable for participation in the trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Procedure Success Rate;6-Month Clinical Success Rate;

Secondary

MeasureTime frame
Adverse Events;Serious Adverse Events;Device Defects;Product Performance;Operational and Ablation-Related Outcomes;

Countries

China

Contacts

Public ContactZeng Rui

West China Hospital, Sichuan University

zengrui_0524@126.com+86 189 8060 6560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026