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

NCT07130175 | Completed

• 1 other identifier: 2022109
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Polymorphic Ventricular Tachycardia; Heart Failure

Outcome Measures

Primary Outcomes (4)

• Change in Left Ventricular Ejection Fraction (LVEF)

  Measured by Cardiac Magnetic Resonance (CMR) imaging to assess global systolic function.

  Baseline, 6 Months Post-treatment

• Change in Left Ventricular End-Diastolic Volume (LVEDV)

  Measured by CMR to assess cardiac size and remodeling.

  Baseline, 6 Months Post-treatment

• Change in Left Ventricular End-Systolic Volume (LVESV)

  Measured by CMR to assess cardiac size and remodeling.

  Baseline, 6 Months Post-treatment

• Change in Stroke Volume (SV)

  Measured by CMR as the difference between LVEDV and LVESV.

  Baseline, 6 Months Post-treatment

Secondary Outcomes (6)

• Total Clinical Effective Rate

  6 Months Post-treatment

• Change in Serum Heart-type Fatty Acid-Binding Protein (H-FABP)

  Baseline, 6 Months Post-treatment

• Change in Serum Soluble ST2 (sST2)

  Baseline, 6 Months Post-treatment

• Change in Serum Galectin-3 (Gal-3)

  Baseline, 6 Months Post-treatment

• Change in Serum Tissue Inhibitor of Metalloproteinase-1 (TIMP-1)

  Baseline, 6 Months Post-treatment

Study Arms (2)

Experimental: Radiofrequency Catheter Ablation (RFCA) Group

EXPERIMENTAL

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.

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

Active Comparator: Control Group

ACTIVE COMPARATOR

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.

Drug: Guideline-Directed Medical Therapy (GDMT)

Interventions

Radiofrequency Catheter Ablation 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.

Experimental: Radiofrequency Catheter Ablation (RFCA) Group

Guideline-Directed Medical Therapy (GDMT) 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; Experimental: Radiofrequency Catheter Ablation (RFCA) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qian Feng: lead
• The First Hospital of Zhangjiakou City: collaborator

Study Sites (1)

The First Hospital of Zhangjiakou City

Zhangjiakou, Hebei, 075100, China

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: December 31, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

CN (1)