BAROSTIM NEO Hypertension Pivotal Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CVRx, Inc.
- 入组人数
- 10
- 试验地点
- 23
- 主要终点
- To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System.
研究概览
简要总结
The purpose of this clinical investigation (NCT01679132) is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM Hypertension Pivotal Trial (G120137).
详细描述
The BAROSTIM NEO Hypertension Trial is a prospective, randomized, controlled trial assessing the safety and efficacy of the BAROSTIM NEO System in subjects with resistant hypertension.
All subjects are now in long term follow-up and are required to have at least one annual visit.
Parameters assessed during visits are:
- Office Cuff Blood Pressure
- Physical Assessment
- Subject Medications
- Serious adverse events
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Actively participating in the Barostim Hypertension Pivotal Trial and currently implanted with the BAROSTIM NEO device with the device turned ON.
- •Have signed a revised approved informed consent form for continued participation in this study.
排除标准
- •Treating physician decision that the subject should not continue with therapy.
研究组 & 干预措施
BAROSTIM NEO System
Subjects implanted with the BAROSTIM NEO System.
干预措施: BAROSTIM NEO System and Medical Management (Device)
结局指标
主要结局
To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System.
时间窗: For the duration of the study, up to ten years.
Ascertain the type, frequency, severity and timing of long-term adverse events in G120137 study subjects implanted with the device, while providing a viable treatment option to patients currently implanted with the CVRx BAROSTIM NEO System.
次要结局
未报告次要终点