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A Prospective, Multicenter, Single-Group, Target-Value Clinical Trial of the Safety and Efficacy of a Cardiac PFA System and a Focal PFA Catheter Together for the Treatment of Ventricular Arrhythmias

A Prospective, Multicenter, Single-Group, Target-Value Clinical Trial of the Safety and Efficacy of a Cardiac PFA System and a Focal PFA Catheter Together for the Treatment of Ventricular Arrhythmias

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099183
Enrollment
Unknown
Registered
2025-03-19
Start date
2025-03-25
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular arrhythmia

Interventions

Ventricular arrhythmia of the outflow tract:Using pulsed electric fields to ablate ventricular arrhythmias.

Sponsors

Fu Wai Hospital, Chinese Academy of Medical Sciences, Fu Wai, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.18 years old 10,000 beats/24h or symptomatic premature beats on ambulatory electrocardiography), who are proposed to undergo catheter-based ablation therapy; 3.Those who agreed to participate in this study and voluntarily signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with other symptomatic arrhythmias such as polygenic premature ventricular beats/ventricular tachycardia requiring pharmacologic control; 2.Patients with a previous history of ventricular fibrillation (VF); 3.Patients with atrial pre-systole, atrial tachycardia, atrial fibrillation, supraventricular tachycardia, and other symptomatic arrhythmias requiring pharmacologic control; 4.Patients with myocardial infarction or unstable angina within 90 days; 5.Patients who have undergone cardiac surgery or percutaneous coronary intervention PCI.within 90 days; 6.Patients with left ventricular ejection fraction LVEF. 2 times the upper limit of normal values); 11.Clinically significant mitral stenosis or regurgitation, any heart valve prolapse, or after valve replacement; 12.Patients with severe restrictive or obstructive lung disease or chronic respiratory disease that, in the judgment of the investigator, precludes cardiac surgery; 13.Patients with severe gastrointestinal bleeding; 14.Presence of a left ventricular assist device LVAD.or planned LVAD or heart transplantation; 15.Patients with life expectancy of less than 1 year, such as a history of malignant tumors and end-stage diseases; 16.Females who are pregnant or breastfeeding or who are planning to have a baby during the study period; 17.Patients who are participating in clinical trials of other drugs or medical devices; 18.Patients who, in the opinion of the investigator, are not suitable for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Acute Success Rate;

Countries

China

Contacts

Public ContactYan Yao

Fu Wai Hospital, Chinese Academy of Medical Sciences, Fu Wai, China

2267118502@qq.com+86 10 8832 2405

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026