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A multicenter Randomized Controlled Trial Comparing the Safety and Efficacy of Pulsed Field Ablation Versus Radiofrequency Ablation for Ventricular Arrhythmias

A multicenter Randomized Controlled Trial Comparing the Safety and Efficacy of Pulsed Field Ablation Versus Radiofrequency Ablation for Ventricular Arrhythmias

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104946
Enrollment
Unknown
Registered
2025-06-25
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-06-30

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

Conditions

Ventricular Arrhythmias

Interventions

PFA group:Use of a disposable magnetic field-guided pressure-monitoring Pulsed Field Ablation catheter (Huikang) in combination with the HT-9000 PRO 3D mapping system
RFA group:Use of ThermoCool SmartTouch ST or SF catheter for standard radiofrequency ablation with usual power settings

Sponsors

Weifang People‘s Hostipal
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years 2. Clearly diagnosed symptomatic ventricular arrhythmias (PVCs >=10% load or sustained/non-sustained VT) 3. Agree and sign the informed consent form

Exclusion criteria

Exclusion criteria: 1.Unstable heart failure, severe valvular disease, etc. 2.History of sudden cardiac death 3.Pregnant women 4.Patients with an ICD and a history of frequent shocks 5.VT originating near the atrioventricular node or the proximal conduction system 6.Contraindications to radiofrequency or electrophysiological testing

Design outcomes

Primary

MeasureTime frame
Immediate postoperative ablation success rate (target arrhythmia cannot be induced);Arrhythmia recurrence rate within 3 months (as judged by Holter or implanted monitoring devices);Incidence of major adverse events (cardiac tamponade, atrioventricular block, coronary artery injury, etc.);

Countries

China

Contacts

Public ContactChen Yanbo

The First Affiliated Hospital of Shandong Second Medical University (Weifang People's Hospital)

cyb0222@126.com+86 151 6646 0788

Outcome results

None listed

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