Active, not recruitingNo phase
Combined Pulsed Field and Radiofrequency Energy for Ablation of Ventricular Tachycardia
Key facts
- Who runs it
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Where
- Canada3 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 30 people, planned
- Started
- 28 Jul 2025
- Expected to end
- Jan 2027
- Type of study
- Interventional
- Treatments tested
- Catheter ablation using sequential radiofrequency and pulsed field ablation
- Record updated
- 20 October 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- 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 take part
- Enrolled in an investigational study evaluating another device or drug
- Previous VT ablation within a year
- 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
- 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
- Uncontrolled heart failure
- Serum creatinine of ≥ 2.5 mg/dl (221 umol/L)
- Thrombocytopenia (< 50 x 109/L) or coagulopathy
- Definite protruding LV thrombus on pre-ablation imaging
- Contraindication to heparin
- Women who are pregnant
- Severe aortic stenosis or flail mitral valve
- Significant congenital anomaly or medical problem that in the opinion of the principal Investigator would preclude enrollment in the study
- Unwilling to participate in the study or unavailable for follow up visits
- Epicardial mapping or ablation is anticipated or planned before the VT ablation procedure
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- Ablation groupTreatment being tested
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.
Treatment: Catheter ablation using sequential radiofrequency and pulsed field ablation
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Thermocool SmartTouch SF Catheter With the Trupulse™ Generator for Endocardial Ablation in Patients With Ventricular Tachycardia
- Record updated
- 20 October 2026