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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
McGill University Health Centre
RECRUITING
Montreal
Montreal Heart Institute
RECRUITING
Montreal
IUCPQ
NOT_YET_RECRUITING
Québec
Contact Information
Primary
Atul Verma, MD
atul.verma@mcgill.ca
514-934-1934
Backup
Atul Verma
atul.verma@mcgill.ca
Time Frame
Start Date: 2025-07-28
Estimated Completion Date: 2026-08
Participants
Target number of participants: 30
Treatments
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.
Sponsors
Leads: McGill University Health Centre/Research Institute of the McGill University Health Centre

This content was sourced from clinicaltrials.gov