NCT01486056已完成不适用
ECG Vector Determination for Model 106 Generator Implant Site Selection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- To correlate ECG amplitude with prospective VNS implant sites.
研究概览
简要总结
This is a prospective, unblinded, non-randomized, descriptive study designed to collect ECG data.
详细描述
This is a prospective, unblinded, non-randomized, descriptive study designed to collect ECG data and determine the process for proper generator and lead placement. The study will be conducted in two phases: Phase I includes ECG data collection from human subjects; Phase II, the Implant Instructions for Use will be evaluated by Cyberonics' Clinical Engineers based on the activities of five to eight experienced VNS surgeons.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 12 years old and in general good health for Phase I. At least 18 years old and in general good health for Phase II.
- •Patients or their guardians must be willing to provide signed informed consent/assent and HIPAA authorization. Note: Patients diagnosed with epilepsy and taking at least 1 antiepileptic medication are desired but not required for the study.
排除标准
- •History of pathologically significant cardiac arrhythmias including but not limited to atrial fibrillation or flutter, chronotropic incompetence, supraventricular tachycardia, ventricular flutter or fibrillation, or implantation of a permanent cardiac pacemaker or defibrillator.
- •Currently present existing signs of skin irritation or rash on the left neck or upper left chest as determined by the PI.
- •History of physical adverse reaction to adhesive electrodes.
结局指标
主要结局
To correlate ECG amplitude with prospective VNS implant sites.
时间窗: up to 2 days
This study is designed to collect ECG data to determine the process for proper generator and lead placement.
次要结局
- To identify potential VNS implant sites associated with low ECG amplitudes.(up to 2 days)
研究者
研究点 (1)
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