Acute Carotid Sinus Endovascular Stimulation II Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in systolic blood pressure during electrical stimulation
研究概览
简要总结
The Acute Carotid Sinus Endovascular Stimulation II (ACES II) Study is a multicenter, prospective, non-randomized study that is being conducted to evaluate the feasibility of endovascular stimulation of carotid sinus nerves via an electrophysiology (EP) catheter advanced into the internal jugular vein (IJV). The current study investigates the hypothesis that intraoperative electrical stimulation of the carotid sinus from the IJV will result in an acute and dose-dependent reduction in blood pressure and heart rate.
详细描述
All study objectives are being assessed during the intraoperative baroreceptor stimulation. No subsequent testing will be performed. The follow-up visit is only intended to assess for adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Subject is at least 18 years old
- •Subject is hypertensive (defined as at least one in-office Systolic BP measurement ≥140 mm Hg or Diastolic BP ≥90 mm Hg within three months prior to enrollment
- •Subject is undergoing a cardiac catheterization involving right heart catheterization and/or EP procedures.
- •Subject (or subject's legally authorized representative) is able and wiling to give informed consent
排除标准
- •Subject has an ejection fraction (EF) less than 35% (by most recent echocardiography in the past 6 months) and there has been no change in clinical status relative to EF
- •Subject is a woman who is pregnant, nursing, or of child bearing potential and is not on a reliable form of birth control
- •Subject is enrolled or is planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from the Medtronic study manager, documenting that there is not a concern that co-enrollment could confound the results of this trial.
- •Subject is unable or unwilling to participate with study procedures
结局指标
主要结局
Change in systolic blood pressure during electrical stimulation
时间窗: Intraoperative testing only
Change in diastolic blood pressure during electrical stimulation
时间窗: Intraoperative testing only
次要结局
- Characterize number and type of side effects seen during stimulation(Intraoperative testing only)