Workflow Study of the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias (VAs)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 12
- 主要终点
- PVC Arm: Effectiveness of the Procedural Workflow
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •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
研究组 & 干预措施
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.
干预措施: Radiofrequency/Pulsed Field Ablation System (Device)
结局指标
主要结局
PVC Arm: Effectiveness of the Procedural Workflow
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- Mapping Time(Intraoperative)
- 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)
- Total Procedure Time(Intraoperative)
- Study Catheter Left Ventricle (LV) and/or Right Ventricle (RV) Dwell Time(Intraoperative)
- Mapping Types(Intraoperative)
- Total Fluoroscopy Time(Intraoperative)
- Fluid Delivered From the Study Catheter(Intraoperative)
- Use of Paralytics(Intraoperative)
- Type of Anesthesia(Intraoperative)
- Number of Ablation Applications(Intraoperative)
- Number of Ablation Applications by Locations(Intraoperative)
- Ablation Parameters: Temperature(Intraoperative)
- Ablation Parameters: Power(Intraoperative)
- Ablation Parameters: Impedance(Intraoperative)
- Ablation Parameters: Contact Force (CF)(Intraoperative)
- Ablation Parameters: PF-only, RF-only, PF/RF, RF/PF Ablations Procedures(Intraoperative)
- Ablation Parameters: Radiofrequency (RF) Power(Intraoperative)
- Ablation Parameters: Application Time(Intraoperative)
- Ablation Parameters: Pulsed Field/Radiofrequency Tag Index per Location(Intraoperative)