试验速览
- 阶段
- 不适用
- 发起方
- CVRx, Inc.
- 入组人数
- 98
- 试验地点
- 46
- 主要终点
- Heart failure metric improvements from baseline
研究概览
简要总结
The purpose of this clinical investigation is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM® HOPE4HF Trial (NCT01720160).
详细描述
A prospective, randomized study describing the safety and efficacy of the BAROSTIM NEO System in heart failure subjects with left ventricular ejection fraction equal to or less than 35 percent. Seventy two subjects were randomized; 32 to the medical management arm and 40 to the device arm (38 implanted, 2 withdrawn). The study closed to new enrollments on January 31, 2014. Subjects are in long-term follow-up and are required to have at least one annual visit. During the visit, there will be a physical assessment, a review of medications and serious adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Actively participating in the BAROSTIM HOPE4HF Study 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
Device
- BAROSTIM NEO System and 2) standard of care medical management therapy for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
干预措施: BAROSTIM NEO® System (Device)
Device
- BAROSTIM NEO System and 2) standard of care medical management therapy for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
干预措施: Standard of care medical managment therapy for heart failure (Other)
Medical Management
Standard of care medical management therapy for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
干预措施: Standard of care medical managment therapy for heart failure (Other)
结局指标
主要结局
Heart failure metric improvements from baseline
时间窗: 12 months
To describe changes in measures compared to baseline.
System and procedure related adverse events
时间窗: 6 months
To demonstrate the safety of the Neo system in a heart failure population.
次要结局
未报告次要终点