NCT03093051终止不适用
A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Unpinning Termination Therapy in Patients With VT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 14
- 主要终点
- Arrhythmia Termination as assessed by the number of episodes restored to sinus rhythm
研究概览
简要总结
This observation study evaluates the safety and performance of UPT therapy in subjects during either an indicated ventricular tachycardia ablation procedure or an ICD implant procedure.
详细描述
This non-blinded, single-arm open-label, phase 1 pilot, acute research feasibility trial aims to demonstrate that the safety and effectiveness of Unpinning Termination (UPT) electrotherapy observed in the canine can be translated to humans and to demonstrate the safety and performance of UPT electrotherapy in the human population most likely to benefit from this therapy. This study evaluates the safety and performance of UPT therapy in subjects during either an indicated ventricular tachycardia (VT) catheter ablation or an indicated initial implant or device replacement of an implantable cardioverter defibrillator (ICD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must meet all of the following inclusion criteria:
- •Life expectancy of 1 year or greater
- •Male or female between 18 and 80 years of age
- •Willing and able to comply with the study protocol, provide a written informed consent
- •Indication for an endocardial VT catheter ablation for symptomatic VT with use of CESS V1.0 or CESS V1.1 OR an indication for an ICD procedure (de novo implant, replacement or upgrade) or de novo CRTD procedure for the risk of or presence of VT (CESS 1.0 and 1.1)
- •Etiology of arrhythmia, or risk of arrhythmia being ischemic cardiomyopathy or non-ischemic cardiomyopathy
- •Medically stable at time of consent to undergo DFT testing performed under general anesthesia or conscious sedation as determined by the investigator
排除标准
- •The subject must not meet any of the following exclusion criteria:
- •Medically unstable at time of study and unsafe to undergo DFT testing under general anesthesia or conscious sedation as determined by the investigator
- •Hemodynamic instability as determined by the investigator
- •AF or atrial flutter at time of Study Procedure and no anticoagulation for preceding 3 weeks and no preoperative transesophageal echocardiographic, Cardiac CT or Intracardiac echocardiographic confirmation of the absence of LA thrombus
- •Presence of intracardiac thrombus
- •Inability to pass catheters to heart due to vascular limitations
- •Cardiovascular anatomical defects that would complicate placement of the lead or catheter required by the protocol, including congenital heart disease and cardiac vein anomalies as determined by the investigator
- •Pregnancy confirmed by test within 7 days of procedure
- •Presence of a chronically implanted lead in the CS
- •Presence of a ventricular assist device, including intra-aortic balloon pump
- •Subjects indicated for VT ablation and experiencing VF
- •Subjects requiring the use of inotropes and/or vasopressors for hemodynamic support within the 3 days prior to the study
- •Prior VT catheter ablation with associated hemodynamic compromise despite pressor agents or stroke
- •Incessant VT/VF or VT/VF storm within six months of scheduled procedure
- •LVEF < 20%
- •New York Heart Association (NYHA) Class IV heart failure
- •Planned epicardial VT ablation on the same day as the research study
- •History of hyper-coagulable state that could increase risk of thromboembolic events
- •History of hemodynamic compromise due to valvular heart disease requiring IV inotropes or other circulatory support
- •Unstable coronary artery disease as determined by the investigator
- •Severe proximal three-vessel or left main coronary artery disease, without revascularization as determined by the investigators
- •History of embolic stroke, Transient Ischemic Attack or other thromboembolic event in the past 6 months
- •History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Congenital Heart Anomaly, Cardiac Amyloidosis, Genetic Cardiac Channelopathy or Cardiac Sarcoidosis
- •Cardiovascular surgery or intervention within 1 month prior to enrollment or planned for up to 1 month after enrollment (other than the planned treatment procedure)
- •Morbid obesity: BMI>39 kg/m2
- •Cognitive or mental health status that would interfere with study participation and proper informed consent
- •Presence of mechanical tricuspid valve
- •Active Endocarditis
- •Ventricular arrhythmia with etiology of sarcoid flare
- •Previously implanted lead is under recall by manufacturer or evidence of lead failure as determined by the investigator
- •End Stage Renal Disease on hemodialysis or peritoneal dialysis, or creatinine clearance <15 ml/min
- •Any other medical condition which may affect the outcome of this study or safety of the subject as determined by the investigator
结局指标
主要结局
Arrhythmia Termination as assessed by the number of episodes restored to sinus rhythm
时间窗: During study procedure
Assess the safety and performance of the Cardialen External Stimulation System and safety and performance ofUPT therapy
次要结局
未报告次要终点
研究者
研究点 (14)
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