CHU Dual-Energy Ablation in Ventricular Arrhythmia

NCT07503769 | Enrolling By Invitation

• 1 other identifier: 775102
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premature Ventricular Contractions; Ventricular Tachycardia

Keywords

PVCs; VT

Outcome Measures

Primary Outcomes (1)

• Success rate of catheter ablation

  The primary efficacy endpoints were to evaluate the acute and 3-month follow-up success rate after ablation

  at end of the procedure, 1-month follow-up, 3-month follow-up

Secondary Outcomes (1)

• Immediate success rate of ablation

  immediate ablation

Study Arms (1)

Catheter ablation

EXPERIMENTAL

All enrolled subjects will undergo radiofrequency or pulsed ablation for idiopathic ventricular arrhythmias using the investigational catheter.

Device: ablation

Interventions

ablation DEVICE

All enrolled subjects will undergo radiofrequency or pulsed ablation for idiopathic ventricular arrhythmias using the investigational catheter.

Also known as: Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation Catheter

Catheter ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai MicroPort EP MedTech Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Location

MeSH Terms

Conditions

Ventricular Premature Complexes; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 31, 2026
• Study Start: February 3, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

CN (1)