Combined Pulsed Field and Radiofrequency Energy for Ablation of Ventricular Tachycardia

NCT06816368 | Recruiting DMC

• 1 other identifier: BWI-CS-020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Ventricular Tachycardia (V-Tach)

Keywords

ventricular tachycardia; pulsed field ablation; radiofrequency; combined dual energy; catheter ablation; pilot study; human; clinical trial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Freedom from ventricular tachycardia recurrence at 6 months post-ablation

  From ablation until 6 months post-ablation

• Secondary safety outcome

  From 7 days until 6 months post-ablation

Other Outcomes (1)

• Quality of life using ICDC score

  6 months post-ablation

Study Arms (1)

Ablation group

EXPERIMENTAL

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

Interventions

Catheter ablation using sequential radiofrequency and pulsed field ablation DEVICE

We are using sequential application of radiofrequency and pulsed field ablation to increase lesion depth and better treat ventricular arrhythmias.

Ablation group

Eligibility Criteria

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

You may qualify if:

• 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
• Age ≥18 years
• LVEF ≥ 30% as estimated by echocardiography, contrast ventriculography, radionuclide imaging or cardiac magnetic resonance imaging within the previous 30 days.
• Willing and capable of understanding the objective, risk, and requirement of the study, and providing consent.
• Able and willing to comply with all pre-, post- and follow-up testing and requirements.

You may not qualify if:

• Definite protruding LV thrombus on pre-ablation imaging.
• 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.
• Absence of vascular access to the heart chambers.
• Other disease process likely to limit survival to less than 6 months.
• Class IV heart failure.
• Serum creatinine of ≥ 2.5 mg/dl (221 umol/L).
• Thrombocytopenia (\< 50 x 109/L) or coagulopathy.
• Contraindication to heparin.
• Women who are pregnant.
• 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.
• Acute illness or active systemic infection.
• Severe aortic stenosis or flail mitral valve.
• Uncontrolled heart failure.
• Significant congenital anomaly or medical problem that in the opinion of the principal Investigator would preclude enrollment in the study.
• Enrolled in an investigational study evaluating another device or drug.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (3)

McGill University Health Centre

Montreal, Quebec, Canada

RECRUITING

Montreal Heart Institute

Montreal, Quebec, Canada

RECRUITING

IUCPQ

Québec, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Atul Verma, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Atul Verma, MD

CONTACT

514-934-1934; atul.verma@mcgill.ca

Atul Verma

CONTACT

atul.verma@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology, Principal Investigator, Professor of Medicine, McGill University

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: February 10, 2025
• Study Start: July 28, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)