An interventional study of Catheter ablation using sequential radiofrequency and pulsed field ablation in Ventricular Tachycardia (V-Tach), sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Active, not recruiting at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Not applicable, Interventional, and Treatment
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.
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.
431 studies on the registry are indexed under Tachycardia, Ventricular; 119 are open to participants now.
This study's planned enrollment of 30 is below the median of 64 across 260 interventional studies indexed under Tachycardia, Ventricular.
Browse Tachycardia, Ventricular studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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.
Acute procedural success (elimination of all clinically relevant ventricular tachycardias)
Elimination of all clinically relevant ventricular tachycardias at the end of the procedure.
Time frame: 6 months
Primary Safety Outcome
Primary adverse events (PAE) within 7 days after ablation
Time frame: From ablation procedure until 7 days post-ablation
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
Time frame: From ablation until 6 months post-ablation
Secondary safety outcome
Primary adverse events at 7 days - 6 months after ablation
Time frame: From 7 days until 6 months post-ablation
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.
Time frame: 6 months post-ablation
Plan to share: No — All relevant data will be published at study end in final manuscript. This is a small, pilot, first-in-human study.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
McGill University Health Centre/Research Institute of the McGill University Health Centre