Clinical trial Recruiting at 6 sites Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment90 (estimated)
SponsorBiosense Webster, Inc.
Industry-sponsored
Locations6 sites (Graz and 5 other locations)
StatusRecruiting
StartedJuly 8, 2026
Main results expectedSeptember 30, 2027
Study endsSeptember 30, 2027
Registry record updatedNovember 4, 2026
Trial IDNCT07727057 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.