NCT03169803Unknown不适用
Cardiac Output Autonomic Stimulation Therapy for Acute Heart Failure (COAST-AHF) - System Design Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Arterial blood pressure
研究概览
简要总结
A feasibility study to investigate the safety and performance of the NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System
详细描述
A single-arm, safety study intended to assess safety and system performance, and the feasibility to improve hemodynamics in patients with acute heart failure syndrome using transvenous, cardiac autonomic nerve stimulation (CANS) therapy. In addition, the effects of NeuroTronik CANS Therapy™ on the congestion of patients will be studied. The study proposes that the NeuroTronik CANS Therapy™ System be deployed during the acute heart failure syndrome hospital admission, along with existing standard treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Left Ventricular Ejection fraction < 40%, measured in the last year
- •At least two of the following:
- •Pulmonary Capillary Wedge Pressure > 18 mmHg
- •Pulmonary congestion on Chest X-ray
- •Jugular vein distension
- •Pulmonary rales
- •Dyspnea at rest
- •Two (2) emergency room visits or hospital admissions in the past three (3) months, or three (3) emergency room visits or admissions in the past six (6) months requiring intravenous diuretics, ultrafiltration or in-hospital inotropic therapy.
- •With or without evidence of low perfusion
排除标准
- •Systolic Blood Pressure < 90 mmHg or > 160 mmHg
- •Catecholamine or inotropic therapy within the previous 48 hours
- •Levosimendan within the previous 72 hours
- •Chronic outpatient catecholamine or inotropic therapy
- •Presence of implanted pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy device
- •Presence of or prior vagal nerve stimulator
- •Coronary artery bypass graft surgery, percutaneous coronary intervention, acute myocardial infarction, or valve replacement within prior 1 month
- •Second or third degree heart block
- •History of atrial or ventricular arrhythmias
- •History of mitral or aortic valve stenosis or regurgitation
- •Hypertrophic obstructive or infiltrative cardiomyopathy
- •Prior vagotomy
- •Prior heart transplant
- •Narrow angle glaucoma
- •Renal failure - either on dialysis or serum creatinine > 2.0 mg/dl
- •Hepatic failure - bilirubin, serum glutamic oxaloacetic transaminase, or serum glutamic pyruvic transaminase > four times upper limit of normal
- •Life expectancy < 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
研究组 & 干预措施
Single arm, NeuroTronik CANS Therapy System
Experimental
干预措施: NeuroTronik CANS Therapy™ System (Device)
结局指标
主要结局
Arterial blood pressure
时间窗: 24 hours
Heart Rate
时间窗: 24 hours
次要结局
- Cardiac output(24 hours)
- Pulmonary capillary wedge pressure(24 hours)
研究者
研究点 (1)
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