NCT02301429终止不适用
Model 20105 Lead Study
Medtronic BRC4 个研究点 分布在 4 个国家目标入组 16 人开始时间: 2014年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed.
研究概览
简要总结
The purpose of this study is to evaluate the implant procedure and feasibility of a new lead developed to pace and sense the left chambers of the heart.
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
- •Subject has Cardiac pacing indication for sinus node dysfunction (dual chamber pacemaker)
- •Subject has signed and dated the study-specific informed consent form
- •Subject is 18 years of age or older
- •Subject is willing, able and committed to participate in Baseline and Follow-up and study procedures for the full length of the study
排除标准
- •Subject is indicated for BiV pacemaker or ICD
- •Subject is pacing dependent
- •Subject has a previous Pacemaker System
- •Subject has known coronary venous vasculature that is inadequate for lead placement
- •Subject has unstable angina pectoris or has had an acute myocardial infarction (MI) within the last month
- •Subject has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past three months
- •Subject is not in sinus rhythm at implant
- •Subject has had a heart transplant (patients waiting for heart transplants are allowed in the study)
- •Subject has known renal insufficiency that would prevent them from receiving an occlusive venogram during the implant procedure
- •Subject is contraindicated for <1mg dexamethasone acetate
- •Subject is enrolled in any concurrent drug and/or device study that may confound the results of this study
- •Subject has a terminal illness and is not expected to survive more than 6 months
- •Subject is a pregnant woman or woman of childbearing potential not on adequate birth control.
- •Subject is employed by Medtronic or by the department of any of the investigators or is a close relative of any of the investigators.
- •Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study
- •Subject meets exclusion criteria required by local law.
- •Subject is unable to tolerate an urgent thoracotomy
研究组 & 干预措施
Model 20105
Experimental
Receiving the model 20105 Lead
干预措施: Model 20105 (Device)
结局指标
主要结局
All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed.
时间窗: 1 month
All Implant procedure and lead related adverse events will be collected during the first month post implant and analyzed.
次要结局
未报告次要终点
研究者
研究点 (4)
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