NCT01519739已完成不适用
Clinical Evaluation of Mediguide System in CRT Implants
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- The performance of the MediGuide™ system during CRT implant
研究概览
简要总结
The purpose of this study is to evaluate the safety and performance of the MediGuide™ system during CRT implants.
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
- •Meet clinical indication for implantation of an SJM CRT system according to the current European Society of Cardiology (ESC) Guidelines for cardiac and resynchronization therapy
- •Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement
- •Ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations
排除标准
- •Currently participating in any other clinical study
- •Have prosthetic valves
- •Are pregnant or planning pregnancy in the next 1 month
- •Are less than 18 years of age
- •Have ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction
研究组 & 干预措施
MediGuide Arm
Experimental
干预措施: MediGuide™ (Device)
结局指标
主要结局
The performance of the MediGuide™ system during CRT implant
时间窗: 1 month post CRT implant
Performance will be assessed in terms occurence of adverse events, easy of use and potential benefits.
次要结局
未报告次要终点
研究者
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