A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiosense Webster, Inc.

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

Treatment groups

90 Participants
are divided into 1 treatment group

Sponsors and collaborators