First-In-Human Study for Ultrasound Based Endovascular Carotid Body Ablation in Subjects With Treatment-Resistant Hypertension: A Safety and Feasibility Study
试验速览
- 阶段
- 不适用
- 发起方
- Cibiem, Inc.
- 入组人数
- 39
- 试验地点
- 13
- 主要终点
- Mean reduction in 24-hour ambulatory systolic and diastolic blood pressure
研究概览
简要总结
The carotid body is located at the bifurcation of the internal and external carotid arteries. It is a chemoreceptor that plays a role in the sympathetic nervous system and in the development and maintenance of hypertension. Hypertension is a major cardiovascular risk factor and is associated with coronary artery disease, stroke, chronic kidney disease, and heart failure.
The objective of this study is to assess the effectiveness and safety of a catheter-based system to ablate the carotid body and reduce blood pressure (BP) in patients with resistant hypertension and to confirm sustainability of the treatment benefits long-term as seen following surgical CB removal.
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
- •Mean office SBP ≥160 mmHg and DBP ≥90 mmHg during screen-in period
- •Mean daytime systolic ABPM ≥135 mmHg during screen-in period
- •Adherent to a stable drug regimen of three (3) or more anti-hypertensive medications of different classes (including one (1) diuretic), with no medication changes expected for at least six (6) months post-procedure
- •No change in anti-hypertensive drug prescription (dose, number of medications, or class of medication) for at least six (6) weeks prior to enrollment
- •Negative pregnancy test for women of child-bearing age
- •Willingness and able to comply with follow-up requirements
- •Signed informed consent
排除标准
- •Secondary causes of hypertension
- •Calculated eGFR <30mL/min/1.73m2
- •History of repeated episodes of hypoglycemic unawareness
- •Morbid obesity, defined as Body Mass Index >40 kg/m2
- •Severe obstructive sleep apnea (AHI > 35/hr.)
- •Pacemaker and/or implantable defibrillators
- •History of transient ischemic accident or cerebrovascular accident during six (6) months prior to screening
- •History of acute heart failure, congestive heart failure (NYHA class III-IV), myocardial infarction, unstable angina, coronary bypass or coronary angioplasty during six (6) months prior to screening
- •History of ipsilateral carotid endarterectomy treatment or ipsilateral carotid artery stenting
研究组 & 干预措施
Catheter-Based Carotid Body Ablation
All subjects undergo catheter-based ablation of the carotid body using the Cibiem Transvenous Ultrasound System (CTUS).
干预措施: Catheter-Based Carotid Body Ablation (Device)
结局指标
主要结局
Mean reduction in 24-hour ambulatory systolic and diastolic blood pressure
时间窗: Baseline versus six months post-procedure
Safety as assessed by incidence of major adverse events
时间窗: From procedure to one month post-procedure
Safety assessed as the combined rate of major adverse events defined as all-causes of death, hospitalization for hypertensive crisis not related to confirmed non-adherence with anti-hypertensive medications, and any device or procedure-related serious adverse event.
次要结局
- Composite rate of major adverse events(At 6, 12, 18, and 24 months post-procedure)
- Mean reduction in office systolic and diastolic blood pressure, and home systolic and diastolic blood pressure(Baseline versus 3, 6, 12, 18, and 24 months)
- Proportion of subjects with controlled blood pressure at 6, 12, 18, and 24 months post-procedure(At 6, 12, 18, and 24 months)
- Ventricular morphometric improvements from cardiac MRI measurements(Screening versus 12 and 24 months)