Combined Pulsed Field and Radiofrequency Energy for Ablation of Ventricular Tachycardia (NCT06816368) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
Combined Pulsed Field and Radiofrequency Energy for Ablation of Ventricular Tachycardia
Canada30 participantsStarted 2025-07-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. 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
ā. Age ā„18 years
ā. LVEF ā„ 30% as estimated by echocardiography, contrast ventriculography, radionuclide imaging or cardiac magnetic resonance imaging within the previous 30 days.
ā. Willing and capable of understanding the objective, risk, and requirement of the study, and providing consent.
ā. Able and willing to comply with all pre-, post- and follow-up testing and requirements.
Exclusion criteria
ā. Definite protruding LV thrombus on pre-ablation imaging.
ā. 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.
ā. Absence of vascular access to the heart chambers.
ā. Other disease process likely to limit survival to less than 6 months.
ā. Class IV heart failure.
ā. Serum creatinine of ā„ 2.5 mg/dl (221 umol/L).
What they're measuring
1
Acute procedural success (elimination of all clinically relevant ventricular tachycardias)
Timeframe: 6 months
2
Primary Safety Outcome
Timeframe: From ablation procedure until 7 days post-ablation
Trial details
NCT IDNCT06816368
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre