Ventricular Arrhythmia
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Procedure Success Rate;6-Month Clinical Success Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events;Serious Adverse Events;Device Defects;Product Performance;Operational and Ablation-Related Outcomes; | — |
Countries
China
Contacts
West China Hospital, Sichuan University