NCT07130175

Radiofrequency Ablation for Polymorphic Ventricular Tachycardia With Heart Failure (RFCA for PMVT-HF)

Efficacy of Radiofrequency Catheter Ablation on Improving Cardiac Function in Patients With Polymorphic Ventricular Tachycardia and Coexisting Heart Failure: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Qian Feng · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, controlled trial to investigate the efficacy of radiofrequency catheter ablation (RFCA) combined with guideline-directed medical therapy (GDMT) compared to GDMT alone in patients with polymorphic ventricular tachycardia (PMVT) and coexisting heart failure (HF). The study aims to evaluate whether the addition of RFCA can lead to superior improvements in cardiac function, clinical outcomes, and serum biomarkers at a 6-month follow-up.

Detailed description

The co-occurrence of polymorphic ventricular tachycardia (PMVT) and heart failure (HF) presents a significant clinical challenge with poor prognosis. While guideline-directed medical therapy (GDMT) is standard care, it may not adequately address the arrhythmic substrate. Radiofrequency catheter ablation (RFCA) has proven effective for other arrhythmias in the context of HF, but its role in PMVT is less established. This study tests the hypothesis that RFCA, as an adjunct to GDMT, is superior to GDMT alone in this high-risk population. A total of 118 eligible patients with PMVT and HF were randomized in a 1:1 ratio to receive either RFCA plus GDMT (Study Group) or GDMT alone (Control Group). The primary objective is to compare changes in cardiac function parameters (LVEF, LVEDV, LVESV, SV) assessed by Cardiac Magnetic Resonance (CMR) from baseline to 6 months post-treatment. Secondary objectives include evaluating differences in clinical efficacy, serum biomarkers of myocardial injury and fibrosis (H-FABP, sST2, Gal-3, TIMP-1), and the incidence of adverse events between the two groups. The findings aim to provide robust evidence for RFCA as a therapeutic strategy to improve cardiac function and clinical outcomes for patients with PMVT and HF.

Conditions

• Polymorphic Ventricular Tachycardia
• Heart Failure

Interventions

Type	Name	Description
DEVICE	Radiofrequency Catheter Ablation	An invasive procedure performed under local anesthesia. An electroanatomic mapping system (CARTO 3) was used to identify the arrhythmogenic substrate of the PMVT. Radiofrequency energy was delivered via an irrigated-tip catheter (30-35 W, 43°C, 17 mL/min saline irrigation) to ablate the target sites. The procedural endpoint was the non-inducibility of the clinical arrhythmia. Post-procedure, patients were prescribed amiodarone.
DRUG	Guideline-Directed Medical Therapy (GDMT)	Standard medical therapy for heart failure, including spironolactone (20 mg once daily), metoprolol succinate (25 mg twice daily), and sacubitril/valsartan (50 mg twice daily). Doses were titrated according to patient tolerance and clinical guidelines.

Timeline

• Start date: 2022-12-31
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2025-08-19
• Last updated: 2025-08-19

Locations

1 site across 1 country: China