Medtronic Micra Transcatheter Pacing System Continued Access Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medtronic
- 入组人数
- 285
- 试验地点
- 55
- 主要终点
- Complications
研究概览
简要总结
Medtronic is sponsoring the Micra Continued Access (CA) study to provide continued access to the Micra System while the marketing application is under review by the Food and Drug Administration (FDA).
详细描述
The Micra CA study is a prospective, non-randomized, multi-center, study designed to allow controlled access of the Micra system when used as intended. All subjects enrolled in the Micra CA Study will be prospectively followed from implant, at 6-month intervals until study closure (i.e. FDA approval). Patients with previous or existing inactive implanted cardiac stimulation systems will have additional follow ups.
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 or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- •Subject meets Class I or ll indication for implantation of single chamber ventricular pacemaker and is intended to be implanted with a Micra System
- •Subject able and accessible for follow-up per study requirements
- •Subject is at least 18 years of age
- •Patient is not enrolled in a concurrent drug and/or device study that may confound registry result.
排除标准
- •Subject has had an acute myocardial infraction (AMI) within 30 days of implant
- •Subject has implantation of neurostimulator or any other chronically implanted device which uses current in the body
- •Subject with mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD)
- •Subjects who are morbidly obese and physician believes telemetry communication of ≤5 inches (12.5 cm) could not be obtained with programmer head.
- •Subject who femoral venous anatomy is unable to accommodate a 23 French introducer sheath or implant on the right side of the heart (for example due to obstructions or sever tortuosity) in the opinion of the implanter
- •Subjects with known intolerance to Nickel-Titanium (Nitinol) Alloy
- •Subject for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated
- •Subjects with life expectancy less than 12-months
- •Subject is enrolled in a concurrent drug and/or device study that may confound CA study results
研究组 & 干预措施
Micra Pacemaker Implant
Micra Pacemaker Implant
干预措施: Micra Pacemaker Implant (Device)
结局指标
主要结局
Complications
时间窗: 3 months post last follow up
Micra system and/or procedure-related complication rate
次要结局
未报告次要终点