RecruitingNot ApplicableNCT07727057
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias
Workflow Study of the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias (VAs)
Sponsor
Biosense Webster, Inc.
Enrollment
90 participants
Start Date
Jul 8, 2026
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria5
- 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
- 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 Criteria27
- Incessant ventricular arrhythmia (VA) necessitating hemodynamic support prior to the ablation procedure
- Polymorphic ventricular tachycardia, unstable ventricular tachycardia, or ventricular fibrillation (VF)
- Idiopathic VAs
- Suspected reversible cause of VA (example, electrolyte abnormalities, thyroid disease, drug induced arrhythmia)
- VAs that are thought to be from channelopathies
- Severely compromised left ventricular ejection fraction (LVEF) (less than \[<\] 20 percentage \[%\])
- Uncontrolled heart failure or New York Heart Association (NYHA) Class IV
- Pre-procedure stimulation protocol anticipated to be unsafe at the time of the screening visit (e.g., hemodynamically unstable participants, participants with ventricular fibrillation), per Site Investigator discretion
- Previous Percutaneous Coronary Intervention (PCI) / Myocardial Infarction (MI) within the past 2 months
- Unstable angina pectoris within the past 6 months.
- Presence of intracardiac thrombus on pre-ablation imaging
- Presence of a condition that precludes vascular access (such as inferior vena cava \[IVC\] filter in case of anterograde approach)
- Epicardial mapping or ablation already anticipated or planned at the time of the screening visit (that is, pre-planned epicardial approach before index VA ablation per protocol)
- History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
- Contraindication to contrast agents.
- Life expectancy < 6 months, including advanced heart failure or terminal illness (at the discretion of the Investigator)
- Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 6 months
- Previous VA ablation within 6 months
- Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the clinical investigation
- Significant congenital anomaly or medical problem that in the opinion of the principal Investigator would preclude enrollment in the study
- Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions For Use (IFU)
- Ventriculotomy or atriotomy within the preceding 8 weeks
- Presence of myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
- Prosthetic valves
- Acute illness, active systemic infection, or sepsis
- Current enrollment in an investigational study evaluating another device, biologic, or drug
- Categorized as vulnerable population and requiring special treatment with respect to safeguards of well-being
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Interventions
DEVICERadiofrequency/Pulsed Field Ablation System
Radiofrequency and pulsed field ablation by Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) catheter with the TRUPULSE™ generator will be used.
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT07727057
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