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

MicroPort

Status

Invitation-only

Conditions

Premature Ventricular Contractions

Ventricular Tachycardia

Treatments

Device: ablation

Study type

Interventional

Funder types

Industry

Identifiers

NCT07503769

775102

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.