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Enrolling by Invitation

NCT Number: NCT07503769

CHU Dual-Energy Ablation in Ventricular Arrhythmia

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.

Enrolling by Invitation

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ablation

Device

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

Primary outcomes

  1. Success rate of catheter ablation

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

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

Secondary outcomes

  1. Immediate success rate of ablation

    Time frame: immediate 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.

Sponsors and collaborators

Lead sponsor

Shanghai MicroPort EP MedTech Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: CHU-VA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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