CHU Dual-Energy Ablation in Ventricular Arrhythmia

NCT07503769 — Not applicable, Enrolling by invitation, 10 participants, Shanghai MicroPort EP MedTech Co., Ltd.

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

RegistryNCT07503769, acronym CHU-VA
StatusEnrolling by invitation
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment10 (Estimated)
SponsorShanghai MicroPort EP MedTech Co., Ltd. (Industry)
ConditionsPremature Ventricular Contractions, Ventricular Tachycardia
Interventionsablation (Device)
Datesstart 2026-02-03, primary completion 2026-07-31 (estimated), completion 2026-10-31 (estimated), first posted 2026-03-31, last updated 2026-03-31
Locations1 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

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Catheter ablationExperimentalDevice: ablationAll enrolled subjects will undergo radiofrequency or pulsed ablation for idiopathic ventricular arrhythmias using the investigational catheter.
  • ablation (Device), also known as Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation Catheter: All enrolled subjects will undergo radiofrequency or pulsed ablation for idiopathic ventricular arrhythmias using the investigational catheter.

+Outcome measures

Primary outcomes

  • Success rate of catheter ablation [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

  • Immediate success rate of ablation [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.

+Eligibility

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.

+Locations (1)

FacilityCityCountryStatus
The First Affiliated Hospital of Ningbo UniversityNingbo, ZhejiangChina