Combined Pulsed Field and Radiofrequency Energy for Ablation of Ventricular Tachycardia
The Thermocool SmartTouch SF Catheter With the Trupulse™ Generator for Endocardial Ablation in Patients With Ventricular Tachycardia
McGill University Health Centre/Research Institute of the McGill University Health Centre
30 participants
Jul 28, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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.
Exclusion Criteria18
- 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.
- 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.
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Interventions
We are using sequential application of radiofrequency and pulsed field ablation to increase lesion depth and better treat ventricular arrhythmias.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06816368