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

Overview

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.

Interventions

• 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.

Primary outcome measures

• PVC Arm: Effectiveness of the Procedural Workflow [Time frame: At 3 Months post index ablation procedure]
• SMIVT and SMNIVT arms: Effectiveness of the Procedural Workflow [Time frame: At 6 months post index ablation procedure]
• Occurrence of Primary Adverse Events (PAE) [Time frame: Up to 7 days post index ablation procedure]

Secondary outcome measures (12)

• Occurrence of Serious Adverse Device Effects (SADEs) [Time frame: Up to Day 180 post index ablation procedure]
• Occurrence of Unanticipated Serious Adverse Device Effects (USADEs) [Time frame: Up to Day 180 post index ablation procedure]
• 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]
• 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]
• Acute Effectiveness [Time frame: Intraoperative]
• Total Procedure Time [Time frame: Intraoperative]
• Study Catheter Left Ventricle (LV) and/or Right Ventricle (RV) Dwell Time [Time frame: Intraoperative]
• Mapping Time [Time frame: Intraoperative]
• Mapping Types [Time frame: Intraoperative]
• Total Fluoroscopy Time [Time frame: Intraoperative]
• Fluid Delivered From the Study Catheter [Time frame: Intraoperative]
• Use of Paralytics [Time frame: Intraoperative]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Germany · 3 centers

• RHÖN-KLINIKUM Campus Bad Neustadt — Bad Neustadt an der Saale
• University Hospital of the Ruhr-University of Bochum — Bad Oeynhausen
• TUM Klinikum Deutsches Herzzentrum — München

Austria · 2 centers

• Medizinische Universitat Graz — Graz
• Ordensklinikum Linz GmbH Elisabethinen — Linz

Belgium · 2 centers

• AZORG campus Aalst Moorselbaan — Aalst
• AZ Sint-Jan Brugge — Bruges

France · 2 centers

• CHU de Clermont Ferrand — Clermont-Ferrand
• CHU de Bordeaux - Hospital Haut-Leveque — Pessac

Switzerland · 2 centers

• Inselspital — Bern
• Universitatsspital Zurich — Zurich

Identifiers

NCT: NCT07727057 · BWI202601 · BWI202601

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗