NCT01251185已完成1 期
Extracorporeal Shockwave Myocardial Revascularization(ESMR)Therapy For The Treatment of Chronic Heart Failure.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Medispec
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- The change in the number of myocardial segments that improve their contractility(at rest and at stress)at 6 months post baseline evaluations, evaluated by echocardiography.
研究概览
简要总结
Evaluation of non-invasive treatment modality, using low-intensity extracorporeal shockwaves for treatment of subjects diagnosed with Congestive Heart Failure, with ischemic etiology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patient is male or female 18 years or older.
- •Patient is diagnosed with a Heart Failure with ischemic etiology. Diagnosis is based on medical history, complete physical evaluation, and echocardiography.
- •Patient has documented myocardial segments with impaired contractility. Diagnosis is based on Rest Echo.
- •Patient is diagnosed with no more than 50% of segments akinetic or dyskinetic Diagnosis is based on echocardiography.
- •Patient is classified as NYHA II to IV.
- •Patient should be on a stable dosage of medication for at least 6 weeks prior to enrollment.
- •Patients Ejection Fraction < 50%.
- •Patient is stable and without clinical events for > 3 months.
- •Patient has signed an informed consent form.
- •Patient's condition should be stable and should have a life expectancy of >12 months.
- •Patient's current and past medical condition and status will be assessed using previous medical history, physical evaluation, and the physicians (principle investigator's)medical opinion.
排除标准
- •Patient with intraventricular thrombus.
- •Severe COPD (patients with an FEV1 less than .8 liters).
- •Patient has chronic lung disease including emphysema and pulmonary fibrosis.
- •Patient has active endocarditis, myocarditis or pericarditis.
- •Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization or any ESWT machine for neovascularization of a competitor company within 3 months of entry into the study.
- •Patients who are unwilling or unable to cooperate with study procedure.
- •Patients who are unwilling to quit smoking during the study procedure (including screening phase).
- •Patients who are diagnosed with severe valvular disease (regurgitation or stenosis).
- •Patient is pregnant.
- •Patient with a malignancy in the area of treatment without complete remission within 5 years(lungs, thorax, ribs).
结局指标
主要结局
The change in the number of myocardial segments that improve their contractility(at rest and at stress)at 6 months post baseline evaluations, evaluated by echocardiography.
时间窗: 6 months
An echo examination shall be used to evaluate myocardial contractility post treatments.
次要结局
- 6 Minutes Walk Test (6MWT)(6 months)
研究者
研究点 (2)
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