Polymorphic Ventricular TachycardiaNCT07130175
Radiofrequency Ablation for Polymorphic Ventricular Tachycardia With Heart Failure (RFCA for PMVT-HF)
A study testing Radiofrequency Catheter Ablation and Guideline-Directed Medical Therapy (GDMT) in people with Polymorphic Ventricular Tachycardia and Heart Failure, run by Qian Feng at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polymorphic Ventricular Tachycardia, Heart Failure
- What is being tested?
- Radiofrequency Catheter Ablation and Guideline-Directed Medical Therapy (GDMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Radiofrequency Catheter Ablation on Improving Cardiac Function in Patients With Polymorphic Ventricular Tachycardia and Coexisting Heart Failure: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- Radiofrequency Catheter Ablation, Guideline-Directed Medical Therapy (GDMT)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency Catheter AblationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Guideline-Directed Medical Therapy (GDMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular Ejection Fraction (LVEF)
Measured by Cardiac Magnetic Resonance (CMR) imaging to assess global systolic function.
Measured: Baseline, 6 Months Post-treatment
Change in Left Ventricular End-Diastolic Volume (LVEDV)
Measured by CMR to assess cardiac size and remodeling.
Measured: Baseline, 6 Months Post-treatment
Change in Left Ventricular End-Systolic Volume (LVESV)
Measured by CMR to assess cardiac size and remodeling.
Measured: Baseline, 6 Months Post-treatment
Change in Stroke Volume (SV)
Measured by CMR as the difference between LVEDV and LVESV.
Measured: Baseline, 6 Months Post-treatment
Secondary outcomes (6)
Total Clinical Effective Rate
Assessed based on a composite of ECG improvement (including PVC burden reduction) and improvement in New York Heart Association (NYHA) functional class.
Measured: 6 Months Post-treatment
Change in Serum Heart-type Fatty Acid-Binding Protein (H-FABP)
Measured by ELISA as a biomarker for myocardial injury.
Measured: Baseline, 6 Months Post-treatment
Change in Serum Soluble ST2 (sST2)
Measured by ELISA as a biomarker for myocardial fibrosis and inflammation.
Measured: Baseline, 6 Months Post-treatment
Change in Serum Galectin-3 (Gal-3)
Measured by ELISA as a biomarker for myocardial fibrosis.
Measured: Baseline, 6 Months Post-treatment
Change in Serum Tissue Inhibitor of Metalloproteinase-1 (TIMP-1)
Measured by double-antibody sandwich method as a biomarker related to extracellular matrix regulation.
Measured: Baseline, 6 Months Post-treatment
Incidence of Adverse Events
Number of participants experiencing any adverse events, including procedural complications, medication side effects, and arrhythmia recurrence.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start31 Dec 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polymorphic Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qian Feng
- Sponsor type
- University, hospital or other
- Collaborators
- The First Hospital of Zhangjiakou City
- Responsible party
- Sponsor-investigator, Qian Feng, The Second Affiliated Hospital of Hebei North University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130175
- Sponsor's protocol ID
- 2022109
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Radiofrequency Catheter Ablation on Improving Cardiac Function in Patients With Polymorphic Ventricular Tachycardia and Coexisting Heart Failure: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07130175
- Acronym / sponsor ID
- 2022109
- Conditions
- Polymorphic Ventricular Tachycardia, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Qian FengUniversity, hospital or other
- Collaborators
- The First Hospital of Zhangjiakou City
- Study start
- 31 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Radiofrequency Catheter Ablation (RFCA) Group | Experimental | Device: Radiofrequency Catheter Ablation, Drug: Guideline-Directed Medical Therapy (GDMT)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. |
| Active Comparator: Control Group | Active comparator | Drug: Guideline-Directed Medical Therapy (GDMT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency Catheter AblationAn 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. | Device | Experimental: Radiofrequency Catheter Ablation (RFCA) Group |
| 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. | Drug | Active Comparator: Control Group, Experimental: Radiofrequency Catheter Ablation (RFCA) Group |
Primary outcome
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.
Change in Left Ventricular End-Diastolic Volume (LVEDV)
Time frame: Baseline, 6 Months Post-treatment
Measured by CMR to assess cardiac size and remodeling.
Change in Left Ventricular End-Systolic Volume (LVESV)
Time frame: Baseline, 6 Months Post-treatment
Measured by CMR to assess cardiac size and remodeling.
Change in Stroke Volume (SV)
Time frame: Baseline, 6 Months Post-treatment
Measured by CMR as the difference between LVEDV and LVESV.
6 secondary outcomes
Total Clinical Effective Rate
Time frame: 6 Months Post-treatment
Change in Serum Heart-type Fatty Acid-Binding Protein (H-FABP)
Time frame: Baseline, 6 Months Post-treatment
Change in Serum Soluble ST2 (sST2)
Time frame: Baseline, 6 Months Post-treatment
Change in Serum Galectin-3 (Gal-3)
Time frame: Baseline, 6 Months Post-treatment
Change in Serum Tissue Inhibitor of Metalloproteinase-1 (TIMP-1)
Time frame: Baseline, 6 Months Post-treatment
Incidence of Adverse Events
Time frame: Through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency Catheter Ablation and Guideline-Directed Medical Therapy (GDMT) in people with Polymorphic Ventricular Tachycardia and Heart Failure, run by Qian Feng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular Ejection Fraction (LVEF) (time frame: Baseline, 6 Months Post-treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.