Combined Pulsed Field and Radiofrequency Energy for Ablation of Ventricular Tachycardia (DUAL-VT)

The Thermocool SmartTouch SF Catheter With the Trupulse™ Generator for Endocardial Ablation in Patients With Ventricular Tachycardia

This will be a single arm study evaluating a new ablation technology for performing catheter ablation of ventricular tachycardia. The technology combines novel pulsed field ablation with radiofrequency ablation.

Study Overview

• Status: Active, not recruiting
• Conditions: Ventricular Tachycardia (V-Tach)
• Intervention / Treatment: Device: Catheter ablation using sequential radiofrequency and pulsed field ablation

Detailed Description

One of the limitations of conventional ventricular tachycardia (VT) ablation using radiofrequency (RF) energy is the inability to reach arrhythmogenic tissue deep in the myocardium. Pulsed field (PF) energy, which causes cell death via irreversible electroporation and is non-thermal, may improve outcomes in patients with VT since it has been shown to have better depth penetration in previously scarred tissue. Furthermore, the combination of RF and PF treatment in the same location can increase tissue lesion depth more than either energy alone. This can potentially minimize the need for epicardial ablations, or complex bipolar ablation strategies as well as associated procedural complications. RF and PF have been used extensively for atrial ablation. RF has been the mainstay for all VT ablation but PF use for VT is relatively new.

Pre-clinical work of ventricular ablation procedures in a swine model evaluated the effects of combined and co-localized PF and RF application on cardiac lesion size and their corresponding histological changes. Compared to PF alone ablation, lesion depths and widths were significantly greater in both RF-PF and PF-RF applications. Histology for both combined lesions showed central thermal necrosis surrounded by a hemorrhagic and transitional PF zone. The findings provided evidence for appropriate use of combination therapy in clinical settings.

The design of the study will be carried out as an interventional, prospective, multicenter, single-arm safety and effectiveness evaluation using the Biosense Webster PF/RF Ablation System. The study will enroll subjects with sustained symptomatic VT who are candidates for catheter ablation. Eligible subjects who sign the Informed Consent Form (ICF) and who meet all eligibility criteria will be enrolled and treated with the STSF Catheter in conjunction with the TRUPULSE™ Generator. A maximum sample size of 30 subjects is planned in the study. All study subjects will be followed-up for 6 months after the study procedure.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • McGill University Health Centre
    • Montreal, Quebec, Canada
      • Montreal Heart Institute
    • Québec, Quebec, Canada
      • IUCPQ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with two or more documented spontaneous episodes of sustained symptomatic VT within 3 months or 1 sustained episode of VT or VT storm (two or more VTs in 24 hours) which required device therapy (shock or anti-tachycardia pacing), external cardioversion, escalated antiarrhythmic therapy, and / or hospitalization

   • Documented episodes assessment will be performed by a review of ECGs, hospitalization records, and/or Implantable Cardioverter Defibrillator (ICD) interrogation
   • Patients must have an ICD implanted
2. Age ≥18 years
3. LVEF ≥ 30% as estimated by echocardiography, contrast ventriculography, radionuclide imaging or cardiac magnetic resonance imaging within the previous 30 days.
4. Willing and capable of understanding the objective, risk, and requirement of the study, and providing consent.
5. Able and willing to comply with all pre-, post- and follow-up testing and requirements.

Exclusion Criteria:

1. Definite protruding LV thrombus on pre-ablation imaging.
2. Myocardial infarction (MI) within the preceding 2 months. Patients with incessant VT (present 50% of the time with intervention for a period >12 hrs) may be enrolled if their MI is at least 3 weeks old.
3. Absence of vascular access to the heart chambers.
4. Other disease process likely to limit survival to less than 6 months.
5. Class IV heart failure.
6. Serum creatinine of ≥ 2.5 mg/dl (221 umol/L).
7. Thrombocytopenia (< 50 x 109/L) or coagulopathy.
8. Contraindication to heparin.
9. Women who are pregnant.
10. Cardiac surgery (i.e. ventriculotomy, atriotomy) within the past 2 months. Patients with incessant VT may be enrolled if their surgery is at least 3 weeks old.
11. Acute illness or active systemic infection.
12. Severe aortic stenosis or flail mitral valve.
13. Uncontrolled heart failure.
14. Significant congenital anomaly or medical problem that in the opinion of the principal Investigator would preclude enrollment in the study.
15. Enrolled in an investigational study evaluating another device or drug.
16. Unwilling to participate in the study or unavailable for follow up visits.
17. Previous VT ablation within a year.
18. Epicardial mapping or ablation is anticipated or planned before the VT ablation procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ablation group; Patients in this single arm will all undergo clinically-indicated catheter ablation of ventricular tachycardia using a novel combination ablation device capable of delivering both radiofrequency and pulsed field ablation.	Device: Catheter ablation using sequential radiofrequency and pulsed field ablation; We are using sequential application of radiofrequency and pulsed field ablation to increase lesion depth and better treat ventricular arrhythmias.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute procedural success (elimination of all clinically relevant ventricular tachycardias)	Elimination of all clinically relevant ventricular tachycardias at the end of the procedure.	6 months
Primary Safety Outcome	Primary adverse events (PAE) within 7 days after ablation	From ablation procedure until 7 days post-ablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from ventricular tachycardia recurrence at 6 months post-ablation	Freedom from recurrence (symptomatic or asymptomatic) of monomorphic VT that was targeted at ablation at 6 months following the ablation procedure, plus additional failure modes including acute procedural failure, repeat ablation failure, non-study device failure, AAD failure	From ablation until 6 months post-ablation
Secondary safety outcome	Primary adverse events at 7 days - 6 months after ablation	From 7 days until 6 months post-ablation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life using ICDC score	Quality of life using the ICDC quality of life score. There are 20 questions each ranked on a Likert scale from 0 to 4. Points are given for number of questions showing any concern and the degree of concern for a total of 100 points.	6 months post-ablation

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Atul Verma, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: January 25, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): February 10, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: clinical trial; pilot study; human; catheter ablation; ventricular tachycardia; radiofrequency; pulsed field ablation; combined dual energy
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Pathological Conditions, Signs and Symptoms; Tachycardia, Ventricular
• Other Study ID Numbers: BWI-CS-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All relevant data will be published at study end in final manuscript. This is a small, pilot, first-in-human study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No