CHU Dual-Energy Ablation in Ventricular Arrhythmia (CHU-VA)

Contact-Force Guided Hybrid-Dual-Energy Ultra-Saline-Irrigated Ablation First-in-Man for Ventricular Arrhythmia: CHU VA

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Ventricular Tachycardia; Premature Ventricular Contractions
• Intervention / Treatment: Device: ablation

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China
      • The First Affiliated Hospital of Ningbo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Catheter ablation; All enrolled subjects will undergo radiofrequency or pulsed ablation for idiopathic ventricular arrhythmias using the investigational catheter.	Device: ablation; All enrolled subjects will undergo radiofrequency or pulsed ablation for idiopathic ventricular arrhythmias using the investigational catheter.; Other Names: Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate success rate of ablation	It is defined as the disappearance of the identical outflow tract ventricular arrhythmia that was present pre-ablation, with no inducible sustained identical outflow tract ventricular arrhythmia during 20 minutes of observation following pharmacological and/or electrophysiological stimulation.	immediate ablation

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: VT; PVCs
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Cardiac Complexes, Premature; Tachycardia; Pathological Conditions, Signs and Symptoms; Tachycardia, Ventricular; Ventricular Premature Complexes
• Other Study ID Numbers: 775102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This trial protocol is available in Chinese only and has not yet been translated into English.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No