Enrolling by invitation NCT07503769
CHU Dual-Energy Ablation in Ventricular Arrhythmia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ablation.
- Who it may be relevant to
- Registry conditions: Premature Ventricular Contractions, Ventricular Tachycardia. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Contact-Force Guided Hybrid-Dual-Energy Ultra-Saline-Irrigated Ablation First-in-Man for Ventricular Arrhythmia: CHU VA
Overview
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.
Interventions
- Device ablation
All enrolled subjects will undergo radiofrequency or pulsed ablation for idiopathic ventricular arrhythmias using the investigational catheter.
Primary outcome measures
- Success rate of catheter ablation [Time frame: at end of the procedure, 1-month follow-up, 3-month follow-up]
Secondary outcome measures (1)
- Immediate success rate of ablation [Time frame: immediate ablation]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Ningbo University — Ningbo
Identifiers
NCT: NCT07503769 · 775102