NCT07727057 A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias
| NCT ID | NCT07727057 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Biosense Webster, Inc. |
| Condition | Arrhythmias, Cardiac |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-07-08 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2026-07-08 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 \[\<\] 20 percentage \[%\]) 7. Uncontrolled heart failure or New York Heart Association (NYHA) Class IV 8. 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 9. Previous Percutaneous Coronary Intervention (PCI) / Myocardial Infarction (MI) within the past 2 months 10. Unstable angina pectoris within the past 6 months. 11. Presence of intracardiac thrombus on pre-ablation imaging 12. Presence of a condition that precludes vascular access (such as inferior vena cava \[IVC\] filter in case of anterograde approach) 13. 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) 14. History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran) 15. Contraindication to contrast agents. 16. Life expectancy \< 6 months, including advanced heart failure or terminal illness (at the discretion of the Investigator) 17. Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 6 months 18. Previous VA ablation within 6 months 19. 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 20. Significant congenital anomaly or medical problem that in the opinion of the principal Investigator would preclude enrollment in the study 21. Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions For Use (IFU) 22. Ventriculotomy or atriotomy within the preceding 8 weeks 23. Presence of myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation 24. Prosthetic valves 25. Acute illness, active systemic infection, or sepsis 26. Current enrollment in an investigational study evaluating another device, biologic, or drug 27. Categorized as vulnerable population and requiring special treatment with respect to safeguards of well-being
Contact & Investigator
Johnson & Johnson Medical Clinical Trial
STUDY DIRECTOR
Johnson & Johnson K.K. Medical Company
Frequently Asked Questions
Who can join the NCT07727057 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Arrhythmias, Cardiac. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07727057 currently recruiting?
Yes, NCT07727057 is actively recruiting participants. Contact the research team at KSteenac@its.jnj.com for enrollment information.
Where is the NCT07727057 trial being conducted?
This trial is being conducted at Aalst, Belgium, Bruges, Belgium.
Who is sponsoring the NCT07727057 clinical trial?
NCT07727057 is sponsored by Biosense Webster, Inc.. The principal investigator is Johnson & Johnson Medical Clinical Trial at Johnson & Johnson K.K. Medical Company. The trial plans to enroll 90 participants.