NCT07727057 - A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias | Crick

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 7 days post index ablation procedure

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

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)

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.

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

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.

Time frame: Intraoperative

Total Procedure Time

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

Time frame: 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.

Time frame: Intraoperative

Mapping Time

Mapping time will be reported.

Time frame: Intraoperative

Mapping Types

Types of mapping will be reported.

Time frame: Intraoperative

Total Fluoroscopy Time

Total fluoroscopy time will be reported.

Time frame: Intraoperative

Fluid Delivered From the Study Catheter

Total fluid delivered from the study catheter will be reported.

Time frame: Intraoperative

Use of Paralytics

Use of paralytics will be reported.

Time frame: Intraoperative

Type of Anesthesia

Type of anesthesia used will be reported.

Time frame: Intraoperative

Number of Ablation Applications

Number of ablation applications will be reported.

Time frame: Intraoperative

Number of Ablation Applications by Locations

Number of ablation applications by locations will be reported.

Time frame: Intraoperative

Ablation Parameters: Temperature

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

Time frame: Intraoperative

Ablation Parameters: Power

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

Time frame: Intraoperative

Ablation Parameters: Impedance

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

Time frame: Intraoperative

Ablation Parameters: Contact Force (CF)

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

Time frame: 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.

Time frame: Intraoperative

Ablation Parameters: Radiofrequency (RF) Power

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

Time frame: Intraoperative

Ablation Parameters: Application Time

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

Time frame: Intraoperative

Ablation Parameters: Pulsed Field/Radiofrequency Tag Index per Location

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

Time frame: Intraoperative

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts