Arrhythmias, Cardiac
Conditions
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.
Interventions
DEVICERadiofrequency/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.
Sponsors
Biosense Webster, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PVC Arm: Effectiveness of the Procedural Workflow | 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. |
| SMIVT and SMNIVT arms: Effectiveness of the Procedural Workflow | 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. |
| Occurrence of Primary Adverse Events (PAE) | 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
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Serious Adverse Device Effects (SADEs) | 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. |
| Occurrence of Unanticipated Serious Adverse Device Effects (USADEs) | 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. |
| 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 | 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. |
| 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 | 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. |
| Acute Effectiveness | 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. |
| Total Procedure Time | Intraoperative | Total procedure time is defined as first femoral puncture to last catheter out. |
| Study Catheter Left Ventricle (LV) and/or Right Ventricle (RV) Dwell Time | Intraoperative | Study catheter left ventricle (LV) and/or right ventricle (RV) dwell time during mapping and ablation will be reported. |
| Mapping Time | Intraoperative | Mapping time will be reported. |
| Mapping Types | Intraoperative | Types of mapping will be reported. |
| Total Fluoroscopy Time | Intraoperative | Total fluoroscopy time will be reported. |
| Fluid Delivered From the Study Catheter | Intraoperative | Total fluid delivered from the study catheter will be reported. |
| Use of Paralytics | Intraoperative | Use of paralytics will be reported. |
| Type of Anesthesia | Intraoperative | Type of anesthesia used will be reported. |
| Number of Ablation Applications | Intraoperative | Number of ablation applications will be reported. |
| Number of Ablation Applications by Locations | Intraoperative | Number of ablation applications by locations will be reported. |
| Ablation Parameters: Temperature | Intraoperative | Temperature during ablation per application and by location will be reported. |
| Ablation Parameters: Power | Intraoperative | Power applied during ablation per application and by location will be reported. |
| Ablation Parameters: Impedance | Intraoperative | Impedance recorded during ablation per application and by location will be reported. |
| Ablation Parameters: Contact Force (CF) | Intraoperative | Contact force applied during ablation per application and by location will be reported. |
| Ablation Parameters: PF-only, RF-only, PF/RF, RF/PF Ablations Procedures | Intraoperative | Participants with PF-only, RF-only, PF/RF, RF/PF ablations per application and by location will be reported. |
| Ablation Parameters: Radiofrequency (RF) Power | Intraoperative | RF power applied during ablation per application and by location will be reported. |
| Ablation Parameters: Application Time | Intraoperative | Application time for ablation per application and by location will be reported. |
| Ablation Parameters: Pulsed Field/Radiofrequency Tag Index per Location | Intraoperative | PF/RF tag index recorded per anatomical location during ablation will be reported. |
Countries
Belgium
Contacts
CONTACTKatie Steenackers, MD
STUDY_DIRECTORJohnson & Johnson Medical Clinical Trial
Johnson & Johnson K.K. Medical Company
Outcome results
None listed