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Completed

NCT Number: NCT07130175

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Zhangjiakou City

Zhangjiakou, Hebei, 075100, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Left Ventricular Ejection Fraction (LVEF)

    Time frame: Baseline, 6 Months Post-treatment

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

  2. Change in Left Ventricular End-Diastolic Volume (LVEDV)

    Time frame: Baseline, 6 Months Post-treatment

    Measured by CMR to assess cardiac size and remodeling.

  3. Change in Left Ventricular End-Systolic Volume (LVESV)

    Time frame: Baseline, 6 Months Post-treatment

    Measured by CMR to assess cardiac size and remodeling.

  4. Change in Stroke Volume (SV)

    Time frame: Baseline, 6 Months Post-treatment

    Measured by CMR as the difference between LVEDV and LVESV.

Secondary outcomes

  1. Total Clinical Effective Rate

    Time frame: 6 Months Post-treatment

    Assessed based on a composite of ECG improvement (including PVC burden reduction) and improvement in New York Heart Association (NYHA) functional class.

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

    Time frame: Baseline, 6 Months Post-treatment

    Measured by ELISA as a biomarker for myocardial injury.

  3. Change in Serum Soluble ST2 (sST2)

    Time frame: Baseline, 6 Months Post-treatment

    Measured by ELISA as a biomarker for myocardial fibrosis and inflammation.

  4. Change in Serum Galectin-3 (Gal-3)

    Time frame: Baseline, 6 Months Post-treatment

    Measured by ELISA as a biomarker for myocardial fibrosis.

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

    Time frame: Baseline, 6 Months Post-treatment

    Measured by double-antibody sandwich method as a biomarker related to extracellular matrix regulation.

  6. Incidence of Adverse Events

    Time frame: Through study completion, an average of 6 months

    Number of participants experiencing any adverse events, including procedural complications, medication side effects, and arrhythmia recurrence.

Sponsors and collaborators

Lead sponsor

Qian Feng

Other

Collaborators

  • The First Hospital of Zhangjiakou City

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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