Rheos Feasibility Trial- A Study of Baroreflex Hypertension TherapyTM in Refractory Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- CVRx, Inc.
- 入组人数
- 16
- 主要终点
- Rheos Feasibility Study
研究概览
简要总结
The Rheos Feasibility Trial is designed to assess safety, device performance, and protocol parameters of the CVRx Rheos Baroreflex Therapy in patients with severe hypertension that are refractory to full drug therapy.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 21 years of age.
- •Have been assessed to have bilateral carotid bifurcations located at or below C3-C
- •Have an office cuff systolic blood pressure greater than or equal to 160 mmHg and a 24-hour ambulatory systolic blood pressure greater than or equal to 150 mmHg despite at least one month of full therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic.
- •Must be certified by the investigator hypertension specialist as compliant with taking full doses of medication.
- •Have signed a CVRx approved informed consent for participation in this study.
排除标准
- •Have been diagnosed with:
- •Baroreflex failure
- •Cardiac bradyarrhythmias
- •Chronic atrial fibrillation
- •Had a heart transplant
- •Have carotid atherosclerosis producing a 50% or greater reduction in linear diameter as determined by ultrasound or angiographic evaluation as determined within six months of enrollment in the trial.
- •Have Grade C ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation.
- •Have prior surgery or radiation in either carotid sinus region.
- •Currently have implanted electrical medical devices such as cardiac pacing, defibrillation or neurologic stimulation systems.
- •Are pregnant or contemplating pregnancy during the 13-month follow-up period.
- •Currently undergoing dialysis.
- •Have hypertension secondary to a treatable cause.
- •Have clinically significant cardiac valvular disease.
- •Are unable or unwilling to fulfill the protocol medication compliance and follow-up requirements.
- •Are unlikely to survive the protocol follow-up period.
- •Are enrolled in another concurrent clinical trial.
研究组 & 干预措施
Rheos Device
干预措施: Implantation of the Rheos System (Device)
Medical Management
干预措施: Standard of care medical management (Other)
结局指标
主要结局
Rheos Feasibility Study
时间窗: 13 months
To summarize the efficacy of the Rheos System by estimating the reduction of systolic blood pressure associated with activation of the Rheos System at 4 and 13 months post implant when compared to baseline (1-month post implant). To describe the safety of the Rheos System by summarizing all system related adverse events and estimating the serious sytem related event-free rate through 4 and 13 months post-implant.
次要结局
未报告次要终点