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

Qian Feng

Status: Completed

Conditions: Polymorphic Ventricular Tachycardia; Heart Failure

Treatments: Device: Radiofrequency Catheter Ablation; Drug: Guideline-Directed Medical Therapy (GDMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT07130175

2022109

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of polymorphic ventricular tachycardia (PMVT) and coexisting heart failure (HF) via ECG and clinical evaluation.
• New York Heart Association (NYHA) functional class II-IV.
• First-time candidate for RFCA.
• Provided written informed consent.

Exclusion criteria

• Diagnosis of a malignant tumor.
• Severe psychiatric disorders.
• History of thyroid diseases or collagen diseases.
• Recent infectious diseases.
• Severe dysfunction of the lungs, liver, or kidneys.
• Coexisting coagulation disorders.
• Contraindications to amiodarone.
• Pregnancy or lactation.
• Congenital heart disease, cor pulmonale, or other primary structural heart diseases.
• Prior pacemaker implantation.
• Cardiac surgery within the previous 3 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

Experimental: Radiofrequency Catheter Ablation (RFCA) Group

Experimental group

Description:

Patients received Radiofrequency Catheter Ablation (RFCA) in addition to standard Guideline-Directed Medical Therapy (GDMT). GDMT included spironolactone 20 mg/day, metoprolol succinate 25 mg twice daily, and sacubitril/valsartan 50 mg twice daily, titrated as tolerated. Patients were followed for 6 months post-procedure.

Treatment:

Drug: Guideline-Directed Medical Therapy (GDMT)

Device: Radiofrequency Catheter Ablation

Active Comparator: Control Group

Active Comparator group

Description:

Patients received standard Guideline-Directed Medical Therapy (GDMT) alone. The regimen included spironolactone 20 mg/day, metoprolol succinate 25 mg twice daily, and sacubitril/valsartan 50 mg twice daily, titrated as tolerated. Patients were followed for 6 months.

Treatment:

Drug: Guideline-Directed Medical Therapy (GDMT)