ablation: All enrolled subjects will undergo radiofrequency or pulsed ablation for idiopathic ventricular arrhythmias using the investigational catheter.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Ningbo University
Ningbo
Zhejiang
More Shanghai MicroPort EP MedTech Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.