NCT03542123Unknown不适用
Cardiac Output Autonomic Stimulation Therapy for Heart Failure - Hemodynamic Effects
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Left ventricular pressure and volume
研究概览
简要总结
A single-arm study to observe NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System hemodynamic and other physiologic effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Normal sinus rhythm by ECG
- •Men and women 21-75 years old
- •Patients with stable symptomatic heart failure, New York Heart Association (NYHA) class II, III, or IV.
排除标准
- •Systolic Blood Pressure < 90 mmHg or > 160 mmHg
- •Current amiodarone therapy or any other antiarrhythmic therapy
- •Coronary artery bypass graft surgery or percutaneous coronary intervention within prior 1 month
- •Enzyme-positive MI within prior 1 month
- •Patients who have been hospitalized for heart failure and who required the use of HF IV therapy within 30 days before enrollment (measured from release)
- •History of recent severe ventricular arrhythmias
- •Pre-existing carotid artery or cerebral disease
- •Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
- •Patients with prior vagalotomy
- •Patients with current or prior vagal nerve stimulators
- •Subjects with narrow angle glaucoma
- •Renal failure - on dialysis or serum creatinine > 2.0 mg/dl
- •Hepatic failure - bilirubin, SGOT, or SGPT > 4X upper limit of normal
- •Patients with a life expectance < 12 months per physician judgment
- •Women who are pregnant
- •Allergy to fentanyl, midazolam, propofol, eggs, egg products, soybeans, or soy products
- •Subjects unwilling or unable to provide consent for the protocol
研究组 & 干预措施
NeuroTronik CANS Therapy® System
Experimental
干预措施: NeuroTronik CANS Therapy® System (Device)
结局指标
主要结局
Left ventricular pressure and volume
时间窗: One hour
次要结局
- Heart rate(One hour)
研究者
研究点 (1)
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