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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