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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Arrhythmias, Cardiac
• Intervention / Treatment: Device: Radiofrequency/Pulsed Field Ablation System

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katie Steenackers, MD; Phone Number: +32 2 746 39 14; Email: KSteenac@its.jnj.com

Study Locations

• Austria
  • Graz, Austria, 8036
    • Not yet recruiting
    • Medizinische Universität Graz
  • Linz, Austria, 4020
    • Not yet recruiting
    • Ordensklinikum Linz GmbH Elisabethinen
• Belgium
  • Aalst, Belgium, 9300
    • Recruiting
    • AZORG campus Aalst Moorselbaan
  • Bruges, Belgium, 8000
    • Not yet recruiting
    • AZ Sint-Jan Brugge
• France
  • Pessac, France, 33600
    • Withdrawn
    • CHU de Bordeaux - Hospital Haut-Leveque
• Germany
  • Bad Neustadt an der Saale, Germany, 97616
    • Not yet recruiting
    • RHÖN-KLINIKUM Campus Bad Neustadt
  • Bad Oeynhausen, Germany, 32545
    • Not yet recruiting
    • University Hospital of the Ruhr-University of Bochum
  • München, Germany, 80636
    • Not yet recruiting
    • TUM Klinikum Deutsches Herzzentrum
• Switzerland
  • Bern, Switzerland, CH-3010
    • Not yet recruiting
    • Inselspital
  • Zurich, Switzerland, 8091
    • Not yet recruiting
    • Universitätsspital Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 VAs
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Radiofrequency/Pulsed Field Ablation; Participants undergoing catheter ablation for the management of premature ventricular complexes (PVC), sustained monomorphic ischemic ventricular tachycardia (SMIVT) and sustained monomorphic non-ischemic ventricular tachycardia (SMNIVT) will undergo catheter ablation using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) catheter in combination with the TRUPULSE™ generator, with radiofrequency and pulsed field energy delivered primarily as radiofrequency (RF)/pulsed field (PF) stacking applications according to the study procedural workflow.

Device: Radiofrequency/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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PVC Arm: Effectiveness of the Procedural Workflow	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.	At 3 Months post index ablation procedure
SMIVT and SMNIVT arms: Effectiveness of the Procedural Workflow	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.	At 6 months post index ablation procedure
Occurrence of Primary Adverse Events (PAE)	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.	Up to 7 days post index ablation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mapping Time	Mapping time will be reported.	Intraoperative
Total Fluoroscopy Time	Total fluoroscopy time will be reported.	Intraoperative
Occurrence of Serious Adverse Device Effects (SADEs)	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.	Up to Day 180 post index ablation procedure
Occurrence of Unanticipated Serious Adverse Device Effects (USADEs)	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.	Up to Day 180 post index ablation procedure
Occurrence of SAEs	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.	Within 7 days (early-onset), 8 to 30 days and >30 days (late onset) that is up to 6 months post index ablation procedure
Occurrence of Non-Serious Adverse Events (Non-SAEs)	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.	Within 7 days (early-onset), 8 to 30 days and >30 days (late onset) that is up to 6 months post index ablation procedure
Acute Effectiveness	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.	Intraoperative
Total Procedure Time	Total procedure time is defined as first femoral puncture to last catheter out.	Intraoperative
Study Catheter Left Ventricle (LV) and/or Right Ventricle (RV) Dwell Time	Study catheter left ventricle (LV) and/or right ventricle (RV) dwell time during mapping and ablation will be reported.	Intraoperative
Mapping Types	Types of mapping will be reported.	Intraoperative
Fluid Delivered From the Study Catheter	Total fluid delivered from the study catheter will be reported.	Intraoperative
Use of Paralytics	Use of paralytics will be reported.	Intraoperative
Type of Anesthesia	Type of anesthesia used will be reported.	Intraoperative
Number of Ablation Applications	Number of ablation applications will be reported.	Intraoperative
Number of Ablation Applications by Locations	Number of ablation applications by locations will be reported.	Intraoperative
Ablation Parameters: Temperature	Temperature during ablation per application and by location will be reported.	Intraoperative
Ablation Parameters: Power	Power applied during ablation per application and by location will be reported.	Intraoperative
Ablation Parameters: Impedance	Impedance recorded during ablation per application and by location will be reported.	Intraoperative
Ablation Parameters: Contact Force (CF)	Contact force applied during ablation per application and by location will be reported.	Intraoperative
Ablation Parameters: PF-only, RF-only, PF/RF, RF/PF Ablations Procedures	Participants with PF-only, RF-only, PF/RF, RF/PF ablations per application and by location will be reported.	Intraoperative
Ablation Parameters: Radiofrequency (RF) Power	RF power applied during ablation per application and by location will be reported.	Intraoperative
Ablation Parameters: Application Time	Application time for ablation per application and by location will be reported.	Intraoperative
Ablation Parameters: Pulsed Field/Radiofrequency Tag Index per Location	PF/RF tag index recorded per anatomical location during ablation will be reported.	Intraoperative

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.
• Investigators: Study Director: Johnson & Johnson Medical Clinical Trial, Johnson & Johnson Medical

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac
• Other Study ID Numbers: BWI202601 (Other Identifier: Biosense Webster, Inc)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson MedTech is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes