NCT04809701已完成不适用
Evaluation of Different Defibrillation Electrode Configurations for Development of a Non-vascular ICD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- The rate of successful defibrillation of induced VA using each of the two NV-ICD electrode configurations
研究概览
简要总结
This study is designed to evaluate the energy requirements of two different Nonvascular ICD (NV-ICD) electrode configurations for achieving successful defibrillation of ventricular arrhythmias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Patient that is scheduled to undergo surgery requiring midline sternotomy or implantation of a commercially-available TV-ICD or S-ICD system per local guidelines
- •Patient must be at least 18 years of age
- •Subject must provide written informed consent prior to any clinical investigation-related procedure.
排除标准
- •Pacemaker dependency
- •Chronically implanted cardiac implantable electronic device or other device which delivers an electrical current
- •Currently taking amiodarone or a Class IC antiarrhythmic drug
- •Hypertrophic cardiomyopathy
- •Anticipated high risk of stroke
- •Anticipated high surgical risk or risk of infection
- •Severe aortic stenosis
- •Severe proximal three vessel coronary disease (over 70% in each vessel)
- •Greater than 50% left main stem disease
- •Prior surgery or anatomical abnormality that significantly increases implant risk per physician's discretion
- •Medical conditions that preclude defibrillation testing
- •Chronic renal insufficiency including patients on dialysis
- •Subject is currently participating in another clinical investigation.
- •Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with the 1-month phone follow-up requirements of the clinical investigation results.
结局指标
主要结局
The rate of successful defibrillation of induced VA using each of the two NV-ICD electrode configurations
时间窗: During the study procedure
Successful defibrillation is defined as termination of the induced VA to sinus rhythm or other non-life threatening ventricular or escape rhythm (such as atrial fibrillation) as determined by the implanting physician.
次要结局
未报告次要终点
研究者
研究点 (4)
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