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NCT Number: NCT07727057

A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias

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.

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Key information

Conditions

Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medizinische Universitat Graz, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Radiofrequency/Pulsed Field Ablation System

Device

Radiofrequency and pulsed field ablation by Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) catheter with the TRUPULSE™ generator will be used.

Primary outcomes

  1. PVC Arm: Effectiveness of the Procedural Workflow

    Time frame: At 3 Months post index ablation procedure

    Effectiveness of the procedural workflow for PVC arm is defined as reduction in burden at 3 months after the index ablation procedure compared to the baseline burden. PVC burden is defined as the percentage of PVCs relative to the total heartbeats measured during a 24-hour Holter monitoring.

  2. SMIVT and SMNIVT arms: Effectiveness of the Procedural Workflow

    Time frame: At 6 months post index ablation procedure

    Effectiveness of the procedural workflow for SMIVT and SMNIVT arm is defined as freedom from documented recurrence (symptomatic or asymptomatic) of any monomorphic VT based on electrocardiographic data (Holter or >= 30 seconds on ECG or any appropriate ICD therapy) throughout 6 months after the index ablation procedure.

  3. Occurrence of Primary Adverse Events (PAE)

    Time frame: Up to 7 days post index ablation procedure

    Occurrence of PAEs within 7 days of the index ablation procedure where the DE STSF Catheter and TRUPULSE Generator are used will be reported. PAEs include the following adverse events: cardiac tamponade/perforation, phrenic nerve paralysis (permanent), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction (MI), transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), vagal nerve injury/gastroparesis, aggravation or new onset heart failure, coronary artery injury, aortic dissection, and valve injury.

Secondary outcomes

  1. Occurrence of Serious Adverse Device Effects (SADEs)

    Time frame: Up to Day 180 post index ablation procedure

    A SADE is an adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event (SAE). A SAE is any event that led to any of the following: Death, Serious deterioration in the health of a participant that resulted in any of the following: life-threatening illness or injury, permanent impairment of a body structure or a body function, in-patient hospitalization or prolongation of patient hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function, chronic disease and fetal distress, fetal death or a congenital physical or mental impairment or birth defect.

  2. Occurrence of Unanticipated Serious Adverse Device Effects (USADEs)

    Time frame: Up to Day 180 post index ablation procedure

    An USADE is any SAE on health, safety, any life-threatening problem, or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, outcome, or degree of incidence in the current investigational plan or risk analysis report, or any other unanticipated serious problem associated with a device that relates to rights, safety, or welfare of participants.

  3. Occurrence of SAEs

    Time frame: Within 7 days (early-onset), 8 to 30 days and >30 days (late onset) that is up to 6 months post index ablation procedure

    An SAE is any event that led to any of the following: Death, Serious deterioration in the health of a participant that resulted in any of the following: life-threatening illness or injury, permanent impairment of a body structure or a body function, in-patient hospitalization or prolongation of patient hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function, chronic disease and fetal distress, fetal death or a congenital physical or mental impairment or birth defect.

  4. Occurrence of Non-Serious Adverse Events (Non-SAEs)

    Time frame: Within 7 days (early-onset), 8 to 30 days and >30 days (late onset) that is up to 6 months post index ablation procedure

    An Adverse Event (AE) means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in participants, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.

  5. Acute Effectiveness

    Time frame: Intraoperative

    Acute effectiveness (acute success) of the index VA ablation procedure performed using the DE STSF catheter in combination with the TRUPULSE Generator will be reported. It is defined as:

    • PVC arm: Acute success is defined as elimination of the targeted PVC(s) after awaiting period of at least 15 minutes, at the end of the procedure.
    • SMIVT and SMNIVT arms: Acute success is defined as elimination and non-inducibility of any monomorphic VT at the end of procedure.

  6. Total Procedure Time

    Time frame: Intraoperative

    Total procedure time is defined as first femoral puncture to last catheter out.

  7. Study Catheter Left Ventricle (LV) and/or Right Ventricle (RV) Dwell Time

    Time frame: Intraoperative

    Study catheter left ventricle (LV) and/or right ventricle (RV) dwell time during mapping and ablation will be reported.

  8. Mapping Time

    Time frame: Intraoperative

    Mapping time will be reported.

  9. Mapping Types

    Time frame: Intraoperative

    Types of mapping will be reported.

  10. Total Fluoroscopy Time

    Time frame: Intraoperative

    Total fluoroscopy time will be reported.

  11. Fluid Delivered From the Study Catheter

    Time frame: Intraoperative

    Total fluid delivered from the study catheter will be reported.

  12. Use of Paralytics

    Time frame: Intraoperative

    Use of paralytics will be reported.

  13. Type of Anesthesia

    Time frame: Intraoperative

    Type of anesthesia used will be reported.

  14. Number of Ablation Applications

    Time frame: Intraoperative

    Number of ablation applications will be reported.

  15. Number of Ablation Applications by Locations

    Time frame: Intraoperative

    Number of ablation applications by locations will be reported.

  16. Ablation Parameters: Temperature

    Time frame: Intraoperative

    Temperature during ablation per application and by location will be reported.

  17. Ablation Parameters: Power

    Time frame: Intraoperative

    Power applied during ablation per application and by location will be reported.

  18. Ablation Parameters: Impedance

    Time frame: Intraoperative

    Impedance recorded during ablation per application and by location will be reported.

  19. Ablation Parameters: Contact Force (CF)

    Time frame: Intraoperative

    Contact force applied during ablation per application and by location will be reported.

  20. Ablation Parameters: PF-only, RF-only, PF/RF, RF/PF Ablations Procedures

    Time frame: Intraoperative

    Participants with PF-only, RF-only, PF/RF, RF/PF ablations per application and by location will be reported.

  21. Ablation Parameters: Radiofrequency (RF) Power

    Time frame: Intraoperative

    RF power applied during ablation per application and by location will be reported.

  22. Ablation Parameters: Application Time

    Time frame: Intraoperative

    Application time for ablation per application and by location will be reported.

  23. Ablation Parameters: Pulsed Field/Radiofrequency Tag Index per Location

    Time frame: Intraoperative

    PF/RF tag index recorded per anatomical location during ablation will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Katie Steenackers, MD

CONTACT

[email protected]

+32 2 746 39 14

Sponsors and collaborators

Lead sponsor

Biosense Webster, Inc.

Industry

Registry information

Official study title

Workflow Study of the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias (VAs)

Acronym: DEVA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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