tachyarrhythmias
Conditions
Interventions
Treatment Group:All enrolled subjects will undergo radiofrequency or pulsed ablation for idiopathic ventricular arrhythmias using the investigational catheter.
Sponsors
The First Affiliated Hospital of Ningbo University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 75 years old (inclusive); 2. Diagnosis: Clinically confirmed tachyarrhythmia, including: Atrial fibrillation (AF) and Idiopathic ventricular arrhythmia (IVA); 3. Recurrent episodes prior to enrollment, Significant symptomatic burden; 4. Failure of =1 antiarrhythmic drug (AAD) therapy (ineffective response) OR Intolerance to AADs (e.g., due to adverse effects); 5. Capable of understanding the treatment protocol, Voluntarily signs informed consent, Compliant with scheduled examinations, procedures, and follow-ups;
Exclusion criteria
Exclusion criteria: 1. Left atrial thrombosis in patients with atrial fibrillation, excluding idiopathic ventricular arrhythmias; 2. Left atrial anteroposterior diameter =55mm in patients with atrial fibrillation, excluding idiopathic ventricular arrhythmias; 3. Left ventricular ejection fraction (LVEF) =40%; 4. History of ventricular flutter or ventricular fibrillation; 5. Diagnosis of long QT syndrome or arrhythmic cardiomyopathy; 6. Presence of structural or organic heart disease, including hypertrophic cardiomyopathy, dilated cardiomyopathy, ischemic cardiomyopathy, rheumatic heart disease, or congenital heart disease; 7. Previous atrial septal repair surgery or atrial myxoma; 8. In-body implantation of an active implant (e.g., pacemaker, ICD, etc.); 9. NYHA class III-IV cardiac function; 10. History of cerebrovascular disease within the past 6 months (including cerebral hemorrhage, stroke, or transient ischemic attack); 11. Patients who have experienced a cardiovascular event within the past 3 months (including acute myocardial infarction, coronary intervention or coronary artery bypass surgery, artificial valve replacement or repair, atrial or ventricular thoracotomy); 12. Patients with acute or severe systemic infection; 13. Patients with severe liver or kidney disease, malignant tumors, or end-stage diseases, or whose treatment, evaluation, and adherence to this trial are deemed by the investigators to be potentially interfering with the trial; 14. Patients with significant bleeding tendency, hypercoagulable state, or severe hematologic disorders; 15. Patients who have participated in or are currently participating in other clinical trials within the 3 months prior to enrollment; 16. Patients with other circumstances deemed unsuitable for participation in this trial by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of catheter ablation within 3 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate success rate of ablation; | — |
Countries
China
Contacts
Public ContactHuimin Chu
The First Affiliated Hospital of Ningbo University
Outcome results
None listed