Symptomatic CRT Patients: Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence. A Post-Market Registry With the Barostim™ System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- CVRx, Inc.
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Change in Six Minute Hall Walk
研究概览
简要总结
The purpose of this study is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients that are symptomatic despite having received CRT.
详细描述
This is a non-randomized, prospective, multicenter complementary-study of the REBALANCE Registry. Patients who have been implanted with a CRT device at least 6-months prior to enrollment are eligible for this complementary-study. Up to 150 subjects will be enrolled. Data should be obtained from evaluations taken prior to implant, at implant, and every six months after device implant, up to the 36-month visit at which time each patient will be exited from the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients can be included if they were implanted with a cardiac resynchronization therapy (CRT) device at least six months (180 days) prior to informed consent and are planned for a de novo Barostim System implantation. Patients must sign an informed consent form before implantation with the Barostim System in order to participate in this study.
排除标准
- •Patients cannot be enrolled and active in another (e.g. device, pharmaceutical, or biological) clinical study unless approved by the CVRx Clinical department.
结局指标
主要结局
Change in Six Minute Hall Walk
时间窗: 36 months post-implant
Changes in Six Minute Hall Walk distance through 36 months post-implant
次要结局
- Change NYHA Class(6 months post-implant)
- Change in Minnesota Living with Heart Failure Quality of Life(6 months post-implant)