Ventricular Tachycardia (V-Tach)DUAL-VTNCT06816368
Combined Pulsed Field and Radiofrequency Energy for Ablation of Ventricular Tachycardia
A study testing Catheter ablation using sequential radiofrequency and pulsed field ablation in people with Ventricular Tachycardia (V-Tach), run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia (V-Tach)
- What is being tested?
- Catheter ablation using sequential radiofrequency and pulsed field ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesCanada
- Study dates
- 28 Jul 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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).
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- 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.
- Unwilling to participate in the study or unavailable for follow up visits.
- Previous VT ablation within a year.
- Epicardial mapping or ablation is anticipated or planned before the VT ablation procedure.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
McGill University Health Centre
Montreal, Quebec
Montreal Heart Institute
Montreal, Quebec
IUCPQ
Québec, Quebec
About this study
Official title: 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.
Read the 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.
- Conditions
- Ventricular Tachycardia (V-Tach)
- Being tested
- Catheter ablation using sequential radiofrequency and pulsed field ablation
- Keywords
- ventricular tachycardia, pulsed field ablation, radiofrequency, combined dual energy, catheter ablation, pilot study, human, clinical trial
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablation using sequential radiofrequency and pulsed field ablationDevice
We are using sequential application of radiofrequency and pulsed field ablation to increase lesion depth and better treat ventricular arrhythmias.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Catheter ablation using sequential radiofrequency and pulsed field ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute procedural success (elimination of all clinically relevant ventricular tachycardias)
Elimination of all clinically relevant ventricular tachycardias at the end of the procedure.
Measured: 6 months
Primary Safety Outcome
Primary adverse events (PAE) within 7 days after ablation
Measured: From ablation procedure until 7 days post-ablation
Secondary outcomes (2)
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
Measured: From ablation until 6 months post-ablation
Secondary safety outcome
Primary adverse events at 7 days - 6 months after ablation
Measured: From 7 days until 6 months post-ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start28 Jul 2025
- Primary completion30 Sep 2026
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Tachycardia (V-Tach)Studies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atul Verma, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Atul Verma, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816368
- Sponsor's protocol ID
- BWI-CS-020
- Acronym
- DUAL-VT
- Status last verified
- Oct 2026
- First submitted
- 25 Jan 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All relevant data will be published at study end in final manuscript. This is a small, pilot, first-in-human study.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Thermocool SmartTouch SF Catheter With the Trupulse™ Generator for Endocardial Ablation in Patients With Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT06816368
- Acronym / sponsor ID
- DUAL-VT / BWI-CS-020
- Conditions
- Ventricular Tachycardia (V-Tach)
- Keywords
- ventricular tachycardia, pulsed field ablation, radiofrequency, combined dual energy, catheter ablation, pilot study, human, clinical trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 10 Feb 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablation group | Experimental | Device: Catheter ablation using sequential radiofrequency and pulsed field ablationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- 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.
Key exclusion criteria (18 listed)
- 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.
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 |
|---|---|---|
| Catheter ablation using sequential radiofrequency and pulsed field ablationWe are using sequential application of radiofrequency and pulsed field ablation to increase lesion depth and better treat ventricular arrhythmias. | Device | Ablation group |
Primary outcome
Acute procedural success (elimination of all clinically relevant ventricular tachycardias)
Time frame: 6 months
Elimination of all clinically relevant ventricular tachycardias at the end of the procedure.
Primary Safety Outcome
Time frame: From ablation procedure until 7 days post-ablation
Primary adverse events (PAE) within 7 days after ablation
2 secondary outcomes
Freedom from ventricular tachycardia recurrence at 6 months post-ablation
Time frame: From ablation until 6 months post-ablation
Secondary safety outcome
Time frame: From 7 days until 6 months post-ablation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No. All relevant data will be published at study end in final manuscript. This is a small, pilot, first-in-human study.
Related trials for Ventricular Tachycardia (V-Tach)
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Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
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Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
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.
Atul Verma, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation using sequential radiofrequency and pulsed field ablation in people with Ventricular Tachycardia (V-Tach), run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 3 sites in Canada.
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 7 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Acute procedural success (elimination of all clinically relevant ventricular tachycardias) (time frame: 6 months). The study lists 2 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 20 Oct 2026.