Neo Non-Randomized Hypertension Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- CVRx, Inc.
- 入组人数
- 40
- 试验地点
- 18
- 主要终点
- To access long-term adverse events in participants implanted with the BAROSTIM NEO System.
研究概览
简要总结
To assess the long-term safety and efficacy of the BAROSTIM NEO System in trial (NCT01471834) participants.
详细描述
The Neo Non-Randomized Hypertension Study is a non-randomized, open-label, verification study in participants diagnosed with drug resistant hypertension, defined as medical treatment failure for hypertension defined as office cuff systolic blood pressure (SBP) ≥ 140 mmHg despite being prescribed to at least three antihypertensive medications, including a diuretic, in accordance with the AHA guidelines.
Participants should remain on their prescribed anti-hypertensive 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.
All (Canadian) participants are now in long term follow-up and are required to have at least one annual visit.
Parameters assessed during long-term follow-up visits:
- Physical Assessment
- Office Cuff Blood Pressure
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Actively participating in the Neo Non-Randomized Hypertension 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
Participants will be implanted with the BAROSTIM NEO System and will continue to receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs to be determined by the subject'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 and Medical Management
Participants will be implanted with the BAROSTIM NEO System and will continue to receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs to be determined by the subject'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: Medical Management (Drug)
结局指标
主要结局
To access long-term adverse events in participants implanted with the BAROSTIM NEO System.
时间窗: For the duration of the study, up to 10 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 CVRx's BAROSTIM NEO System.
次要结局
未报告次要终点