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A Prospective, Multicenter, Randomized, Controlled Study Comparing the Safety and Efficacy of Pulse Field Ablation and Radiofrequency Ablation for the Treatment of Right Ventricular Outflow Tract–Originated Ventricular Premature Beats

A Prospective, Multicenter, Randomized, Controlled Study Comparing the Safety and Efficacy of Pulse Field Ablation and Radiofrequency Ablation for the Treatment of Right Ventricular Outflow Tract–Originated Ventricular Premature Beats

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111191
Enrollment
Unknown
Registered
2025-10-27
Start date
2025-10-31
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

Ventricular premature contraction originating from the right ventricular outflow tract

Interventions

Experimental group (PFA group):Receiving pulsed electric field ablation treatment.
Control group (RFA group):Radiofrequency ablation treatment

Sponsors

The Second Affiliated Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 75 years old (inclusive), no gender restrictions; 2. The clinical diagnosis was symptomatic premature ventricular contractions; 3. Ventricular extrasystole was monomorphic and originated from right ventricular outflow tract (left bundle branch block in chest leads and high R in inferior leads); 4. 24-hour dynamic electrocardiogram shows a count of more than 10,000 episodes of ventricular premature contractions per 24 hours; 5. The treatment effect of anti-arrhythmic drugs (AADs) is poor, or the patient cannot tolerate or is unwilling to accept the treatment with AADs;

Exclusion criteria

Exclusion criteria: 1. Previous treatment with right ventricular outflow tract catheter ablation; 2. NYHA is classified as III to IV; 3. LVEF 3 times the upper limit of normal, serum creatinine (Cr) > 2 times the upper limit of normal or undergoing dialysis treatment); 7. poorly controlled diabetes mellitus or hypertension; 8. Pregnant or lactating women, as well as those who plan to become pregnant during the course of the study; 9.Pregnant or lactating women and those planning to conceive during the study period; 10. Life expectancy < 12 months; 11. Those who are currently participating in clinical research studies for any other medications or medical devices and have not yet completed their participation; 12. Situations in which it is deemed inappropriate for an individual to participate in this research.

Design outcomes

Primary

MeasureTime frame
Success rate of ablation 90 days post-surgery;

Secondary

MeasureTime frame
Immediate surgical success rate;Surgical procedure duration;LVEF 90 days post-surgery;The incidence rate of major adverse events 90 days after surgery.;X-ray exposure time;Incidence of severe adverse events 90 days post-surgery;PVC load after 90 days post-surgery;Left ventricular end-diastolic diameter 90 days post-surgery.;Dissolution Time;Number of PVCs 90 days post-surgery.;

Countries

China

Contacts

Public ContactFan Yougi

The Second Affiliated Hospital of Zhejiang University School of Medicine

fanyouqi1228@126.com+86 571 87783777

Outcome results

None listed

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