Contact-Force Guided Hybrid-Dual-Energy Ultra-Saline-Irrigated Ablation First-in-Man for Ventricular Arrhythmia: CHU VA
| Registry | NCT07503769, acronym CHU-VA |
|---|---|
| Status | Enrolling by invitation |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 10 (Estimated) |
| Sponsor | Shanghai MicroPort EP MedTech Co., Ltd. (Industry) |
| Conditions | Premature Ventricular Contractions, Ventricular Tachycardia |
| Interventions | ablation (Device) |
| Dates | start 2026-02-03, primary completion 2026-07-31 (estimated), completion 2026-10-31 (estimated), first posted 2026-03-31, last updated 2026-03-31 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Premature Ventricular Contractions All trials for Ventricular Tachycardia All trials of ablation
The objective of this study is to evaluate the safety of the dual-energy ablation catheter manufactured by Shanghai MicroPort EP Medical Technology Co., Ltd. in the treatment of tachyarrhythmias.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Catheter ablation | Experimental | Device: ablation | All enrolled subjects will undergo radiofrequency or pulsed ablation for idiopathic ventricular arrhythmias using the investigational catheter. |
Sex: All, ages: 18 Years to 75 Years
Inclusion Criteria: * Patient age ≥ 18 years and ≤ 75 years; * Clinically diagnosed with tachyarrhythmia, specifically idiopathic ventricular arrhythmia; * Recurrent disease with obvious symptoms prior to enrollment; * Failure to respond to or intolerance of at least one antiarrhythmic drug; * Fully understand the treatment plan, voluntarily sign the informed consent form, and agree to undergo the examinations, procedures and follow-up as required by the protocol. Exclusion Criteria: * Left ventricular ejection fraction (LVEF) ≤ 40% * History of ventricular flutter or ventricular fibrillation * Diagnosis of long QT syndrome or arrhythmogenic cardiomyopathy * Presence of structural heart disease or organic heart disease, including hypertrophic cardiomyopathy, dilated cardiomyopathy, ischemic cardiomyopathy, rheumatic heart disease, and congenital heart disease * Previous atrial septal repair or atrial myxoma * Carrying an active implantable device in the body (e.g., cardiac pacemaker, ICD, etc.) * NYHA functional class Ⅲ-Ⅳ * Patients with documented cerebrovascular disease within the past 6 months (including cerebral hemorrhage, stroke, transient ischemic attack) * Patients with cardiovascular events within the past 3 months (including acute myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting, prosthetic valve replacement or repair, atrial or ventricular incision) * Patients with acute or severe systemic infection * Patients with severe hepatic or renal disease, malignant tumor, or end-stage disease, who, in the investigator's judgment, may interfere with the treatment, evaluation, or compliance of this trial * Patients with significant bleeding tendency, hypercoagulable state, or severe hematological disorders * Patients who have participated in or are currently participating in other clinical trials within 3 months prior to enrollment * Patients with other conditions deemed inappropriate for participation in this trial by the investigator.
| Facility | City | Country | Status |
|---|---|---|---|
| The First Affiliated Hospital of Ningbo University | Ningbo, Zhejiang | China |