Dual Energy ThermoCool SmartTouch SF Catheter with TRUPULSE Generator for Ventricular Arrhythmias
Official title: Workflow Study of the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias (VAs)
Run by Biosense Webster, Inc. · NCT07727057 · Data updated 2026-11-12
This study tests a special catheter and generator setup to treat ventricular arrhythmias and checks that the procedure can be done safely following a specific workflow.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Biosense Webster, Inc. Industry-sponsored |
| Locations | 6 sites (Graz and 5 other locations) |
| Status | Recruiting |
| Started | July 8, 2026 |
| Main results expected | September 30, 2027 |
| Study ends | September 30, 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07727057 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 and older who are planned for catheter ablation to treat PVCs or sustained monomorphic VT with recent symptomatic episodes requiring prior intervention or therapy.
✕Probably not a fit
Patients not undergoing ablation for ventricular arrhythmias or those not meeting the procedural criteria may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study evaluates the safety and effectiveness of using the Dual Energy THERMOCOOL SMARTTOUCH SF catheter with the TRUPULSE generator during catheter ablation for ventricular arrhythmias. The trial focuses on whether the abnormal heart rhythm can be successfully treated while maintaining a predefined procedural workflow, and it monitors post-procedure safety for complications. Participants are adults undergoing ablation for PVCs or sustained monomorphic VT (including ischemic or non-ischemic types) with documented recent episodes. The study collects data on procedural performance and early post-procedural outcomes related to this ablation system.
Why it matters
Potential benefit: If successful, the approach could improve accuracy and safety of ventricular arrhythmia ablation using the DE STSF catheter and TRUPULSE generator.
How similar studies have gone: Previous studies with similar catheter systems have shown potential benefits in ablation performance, but this specific dual-energy workflow with TRUPULSE is being evaluated for safety and effectiveness.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Medizinische Universitat Graz
Graz, Austria Recruiting -
Ordensklinikum Linz GmbH Elisabethinen
Linz, Austria Recruiting -
AZORG campus Aalst Moorselbaan
Aalst, Belgium Recruiting -
AZ Sint-Jan Brugge
Bruges, Belgium Recruiting -
RHÖN-KLINIKUM Campus Bad Neustadt
Bad Neustadt an der Saale, Germany Recruiting -
TUM Klinikum Deutsches Herzzentrum
München, Germany Recruiting
Study contacts
- Study coordinator: Katie Steenackers, MD
- Email: KSteenac@its.jnj.com
- Phone: +32 2 746 39 14
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Can fluoroscopy plus TTE guidance improve leadless pacemaker placement accuracy
This study tests whether using transthoracic echocardiography (TTE) during leadless pacemaker placement improves accuracy and safety compared with standard fluoroscopy.
-
Volta AI software in real-world AF ablation
A real-world observational study will test the latest Volta AF-Xplorer II AI software during atrial fibrillation ablation to see how safe and effective it is over 24 months.
-
Pacing decisions guided by risk for pacing-induced heart muscle weakness
This study tests a risk score to predict pacing-induced cardiomyopathy in adults getting heart rhythm devices, to tailor pacing choices.
-
Heart assessment to check repeat-stroke risk in people with atrial fibrillation
This project will test whether detailed heart examinations can find which people with atrial fibrillation who just had an ischemic stroke are at high risk of having another stroke.
-
Sensor-guided exercise program for people with atrial fibrillation
This program will test whether a Fitbit-based, personalized exercise plan can reduce symptoms and episode burden in people with paroxysmal atrial fibrillation.
-
Understanding brain and heart injuries after bleeding in the brain
This study looks at how bleeding in the brain affects both the brain and the heart in adults to better understand the connection between these injuries.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.