About this trial
The purpose of this study is to collect information about how safe Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) catheter with TRUPULSE™ Generator is and how effective a specific procedural workflow is when this ablation system is used to treat ventricular arrhythmias. The main aims of this study are to see whether the abnormal heart rhythm can be successfully treated while maintaining a specific procedural workflow with the catheter and generator during the cardiac ablation and to monitor participant safety after the procedure by checking if the participant has any complications.
Eligibility criteria
Qualifiers
Participant is planned for a catheter ablation procedure to ablate either: (a) Premature ventricular complexes (PVCs); (b) Sustained monomorphic ventricular tachycardia (VT), including sustained monomorphic ischemic ventricular tachycardia (SMIVT) or sustained monomorphic non-ischemic ventricular tachycardia (SMNIVT), with one or more documented spontaneous episodes of symptomatic sustained monomorphic ventricular tachycardia within 3 months that required device therapy (shock or anti-tachycardia pacing), external cardioversion, escalated antiarrhythmic therapy, and/or hospitalization. Documented episodes will be assessed by review of electrocardiographic data.
Age greater than or equal to 18 years
Willing and capable of providing consent
Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Disqualifiers
Incessant ventricular arrhythmia (VA) necessitating hemodynamic support prior to the ablation procedure
Polymorphic ventricular tachycardia, unstable ventricular tachycardia, or ventricular fibrillation (VF)
Idiopathic VTs
Suspected reversible cause of VA (example, electrolyte abnormalities, thyroid disease, drug induced arrhythmia)
Trial design
Treatments tested in this trial
- Radiofrequency/Pulsed Field Ablation System