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NCT07727057
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias
Conditions: Arrhythmias, Cardiac
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: Biosense Webster, Inc.
Location: Medizinische Universitat Graz Graz
Summary
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
Inclusion criteria:
1. 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.
2. Age greater than or equal to 18 years
3. Willing and capable of providing consent
4. Able and willing to comply with all pre-, post-, and follow-up testing and requirements
5. For participants with sustained monomorphic ventricular tachycardia (SMIVT or SMNIVT): participant must have an implantable cardioverter defibrillator (ICD) already implanted before the ventricular tachycardia ablation procedure, or implantation must be planned during or soon after the ablation procedure, during the same hospital admission
Exclusion criteria:
1. Incessant ventricular arrhythmia (VA) necessitating hemodynamic support prior to the ablation procedure
2. Polymorphic ventricular tachycardia, unstable ventricular tachycardia, or ventricular fibrillation (VF)
3. Idiopathic VTs
4. Suspected reversible cause of VA (example, electrolyte abnormalities, thyroid disease, drug induced arrhythmia)
5. VAs that are thought to be from channelopathies
6. Severely compromised left ventricular ejection fraction (LVEF) (less than \[\
Source: ClinicalTrials.gov (NCT07727057). StuddyBuddy aggregates publicly available trial information.