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

NCT07727057 | Recruiting FDA Device

• 1 other identifier: BWI202601
• Study Type: interventional
• Target: 90
• Locations: 3 countries
• Sites: 4

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.

Conditions

Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (23)

• Occurrence of Serious Adverse Device Effects (SADEs)

  Up to Day 180 post index ablation procedure

• Occurrence of Unanticipated Serious Adverse Device Effects (USADEs)

  Up to Day 180 post index ablation procedure

• Occurrence of SAEs

  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)

  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

  Intraoperative

Study Arms (1)

Radiofrequency/Pulsed Field Ablation

EXPERIMENTAL

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

Interventions

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.

Radiofrequency/Pulsed Field Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Incessant ventricular arrhythmia (VA) necessitating hemodynamic support prior to the ablation procedure
• Polymorphic ventricular tachycardia, unstable ventricular tachycardia, or ventricular fibrillation (VF)
• Idiopathic VTs
• 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.

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (4)

Ordensklinikum Linz GmbH Elisabethinen

Linz, 4020, Austria

RECRUITING

AZORG campus Aalst Moorselbaan

Aalst, 9300, Belgium

RECRUITING

AZ Sint-Jan Brugge

Bruges, 8000, Belgium

RECRUITING

TUM Klinikum Deutsches Herzzentrum

München, 80636, Germany

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Johnson & Johnson Medical Clinical Trial

  Johnson & Johnson K.K. Medical Company

  STUDY DIRECTOR

Central Study Contacts

Katie Steenackers, MD

CONTACT

+32 2 746 39 14; KSteenac@its.jnj.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 27, 2026
• Study Start: July 8, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

BE (2); AU (1); DE (1)