Clinical Investigation of the SelectSecure Pacing Lead
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 365
- 试验地点
- 30
- 主要终点
- 3-month safety (complications and all lead-related adverse events) and efficacy ( pacing and sensing) objectives
研究概览
简要总结
People who have a slow heart beat, or whose heart does not beat on its own, may be in need of an electronic device called a pacemaker. A pacemaker is implanted surgically just under the skin in the upper chest area. This device helps the heart beat at a regular rhythm by sending electrical signals (pacing) directly to the heart tissue through flexible wires called leads. The purpose of this study is to demonstrate that the SelectSecure (Model 3830) lead is safe and effective for both sensing the heart's natural rhythm and pacing the heart when it does not beat on its own. This lead will be studied in both the right atrium and right ventricle. A previously market approved Medtronic lead model will serve as a comparison to prove the safety and effectiveness of the SelectSecure Model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are in need of a pacemaker that paces in both the right atrium and ventricle.
排除标准
- •Subjects who are in need of an implantable cardioverter defibrillator (ICD).
- •Subjects who have a mechanical or diseased tricuspid valve (a structure in the heart, located between the right atrium and right ventricle, which allows blood to flow from the atrium to the ventricle).
- •Steroid contraindication
结局指标
主要结局
3-month safety (complications and all lead-related adverse events) and efficacy ( pacing and sensing) objectives
次要结局
- Lead and catheter handling characteristics, and lead impedance