Neo Randomized Heart Failure Study
试验速览
- 阶段
- 不适用
- 发起方
- CVRx, Inc.
- 入组人数
- 94
- 试验地点
- 30
- 主要终点
- To assess long-term adverse events in Canadian participants implanted with the BAROSTIM NEO System
研究概览
简要总结
The purpose of this portion of study NCT01471860 is to assess the long-term safety and efficacy of the BAROSTIM NEO System in Canadian study participants implanted with the device.
详细描述
The Neo Randomized Heart Failure Study is a prospective, randomized, study describing the safety and efficacy of the BAROSTIM NEO System in the heart failure participants with a left ventricular ejection fraction ≤ 35%.
During long-term follow-up, all participants are required to have at least one annual visit.
Parameters assessed during long-term follow-up visits:
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Actively participating in the Neo Randomized Heart Failure Study.
- •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 and Medical Management
Medical Management, to be determined by the participant's physician, described as:
- Optimal pharmacological therapy: Prescribed to a beta blocker, a diuretic, and an ACE (Angiotensin-converting-enzyme) inhibitor or ARB (Angiotensin Receptor Blocker) unless contraindicated or not tolerated. These drugs must be used in a manner consistent with their labeling.
- Stable pharmacological therapy: No more than a 50% increase or a 50% decrease of the dosage of any one medication, and post titration of all heart failure medications.
Participants should remain on their prescribed heart failure medications and same dosing schedule for the duration of the study unless investigators determine medically necessary changes are needed. Additionally, every effort should be made to maintain adequate rate control for subjects with atrial fibrillation throughout the duration of the study.
干预措施: BAROSTIM NEO System (Device)
Device and Medical Management
Medical Management, to be determined by the participant's physician, described as:
- Optimal pharmacological therapy: Prescribed to a beta blocker, a diuretic, and an ACE (Angiotensin-converting-enzyme) inhibitor or ARB (Angiotensin Receptor Blocker) unless contraindicated or not tolerated. These drugs must be used in a manner consistent with their labeling.
- Stable pharmacological therapy: No more than a 50% increase or a 50% decrease of the dosage of any one medication, and post titration of all heart failure medications.
Participants should remain on their prescribed heart failure medications and same dosing schedule for the duration of the study unless investigators determine medically necessary changes are needed. Additionally, every effort should be made to maintain adequate rate control for subjects with atrial fibrillation throughout the duration of the study.
干预措施: Medical Management (Drug)
结局指标
主要结局
To assess long-term adverse events in Canadian participants implanted with the BAROSTIM NEO System
时间窗: For the duration of the study, up to 5 years.
Ascertain the type, frequency, severity and timing of long-term adverse events in participants implanted with the device, while providing a viable treatment option to participants currently implanted with the BAROSTIM NEO System.
次要结局
未报告次要终点