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

NCT ID: NCT07130175

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2024-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Radiofrequency Catheter Ablation (RFCA) Group

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.

Group Type: EXPERIMENTAL

Radiofrequency Catheter Ablation

Intervention Type: DEVICE

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.

Guideline-Directed Medical Therapy (GDMT)

Intervention Type: DRUG

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.

Active Comparator: Control Group

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.

Group Type: ACTIVE_COMPARATOR

Guideline-Directed Medical Therapy (GDMT)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Zhangjiakou City

UNKNOWN

Sponsor Role: collaborator

Qian Feng

OTHER

Sponsor Role: lead

Responsible Party

Qian Feng

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The First Hospital of Zhangjiakou City

Zhangjiakou, Hebei, China

Countries

China

Other Identifiers

2022109

Identifier Type: -

Identifier Source: org_study_id