Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 586
- 试验地点
- 108
- 主要终点
- LV MSP Feature Related Complication-Free Rate
研究概览
简要总结
Prospective, multi-center, single arm, post approval study to be conducted in the United States.
详细描述
Evaluate the effectiveness of Boston Scientific (BSC)'s LV MSP (Left Ventricular MultiSite Pacing) feature in the Resonate family of CRT-D devices and confirm safety in a post approval study when used in accordance with its approved labeling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Subjects who received de novo implantation of BSC's Resonate family of CRT-D devices with the LV MSP feature4 and BSC's ACUITYTM X4 LV Quadripolar leads. A Resonate family of CRT-D device upgrade from previous single or dual chamber pacemaker or ICD implantation is allowed.
- •Subjects must meet BSC labeled indication for CRT-D implantation.
- •Subjects must have a functional RA lead and RV lead implanted
- •Subjects who are willing and capable of providing informed consent
- •Subjects who are willing and capable of participating in all testing/visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
- •Subjects who are age 18 and above, or of legal age to give informed consent specific to state and national law
排除标准
- •Subjects who received LV pacing prior to receiving the Resonate family of CRT-D system implantation.
- •Subjects who received the LV MSP therapy post CRT-D implantation but prior to enrollment
- •Subjects with documented history of permanent AF
- •Subjects with documented permanent complete AV block
- •Subjects who are expected to receive a heart transplant during the 12 months course of the study
- •Subjects with documented life expectancy of less than 12 months
- •Subjects who enrolled in any other concurrent study or registry, with the exception of mandatory national or governmental registry, without prior written approval from BSC
结局指标
主要结局
LV MSP Feature Related Complication-Free Rate
时间窗: Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration.
Proportion of subjects free from LVMSP feature related complications at 12 months
Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months
时间窗: 12 Month Follow Up
Proportion of non-responders with LV MSP enabled at 6 months who were responders at 12 months. Responders were defined as having an Improved Clinical Composite Score at 12 Months.
次要结局
未报告次要终点