Clinical Research Evaluation of the ASSURE Device Atrial and Ventricular Tachyarrhythmia Therapies Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 36
- 主要终点
- Inappropriate Shock Free Rate
研究概览
简要总结
Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device.
详细描述
The Guidant ASSURE device is a fully featured pacemaker with additional atrial and ventricular tachyarrhythmia therapy features. The REASSURE AV study is a clinical evaluation to support approval of these features. This clinical study is intended to provide adequate performance data on two atrial tachyarrhythmia management features, namely the ATS and atrial ATP. In addition data will be collected to verify that the ventricular tachyarrhythmia rescue shock feature performs as intended in the clinical setting in combination with other pacemaker functions.
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
- •The patient is willing and capable of providing informed consent at an approved clinical investigational center, and able to attend the investigational center as required by the protocol
- •Patient is implanted with an investigational B301 device as part of the REASSURE AV study
排除标准
- 未提供
研究组 & 干预措施
AV Therapy Assessment group
appropriate system performance of the atrial and ventricular tachyarrhythmia therapies in the ASSURE device
干预措施: AV Therapy Assessment-B301 investigational device (Device)
结局指标
主要结局
Inappropriate Shock Free Rate
时间窗: Three months post-implant
Incidences of ventricular shock therapy up to three months post implant. Rescue shocks are intended for the treatment of cardiac arrhythmias detected in the ventricle at rates greater than 220 bpm, including arrhythmias that originate in the atria if they are conducted at rates greater than 220 bpm as this can be life threatening if persistent. Shocks delivered for other reasons will be considered inappropriate shocks.
次要结局
- Conversion Success Rate up to Three Months Post-implant(Three months post-implant)