NCT02645539Unknown不适用
A Clinical Study to Evaluate Ambulatory Counterpulsation for the Treatment of Advanced Heart Failure: A Feasibility Study
NuPulseCV34 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 34
- 主要终点
- Survival to transplant or stroke-free survival
研究概览
简要总结
The purpose of this feasibility study is to assess the preliminary safety and clinical performance of the intravascular ventricular assist system (iVAS).
详细描述
This is a single-arm, non-randomized study designed to assess the preliminary safety and clinical performance of the NuPulseCV iVAS.
Data obtained from the study will be used to make device modifications, refine the patient population, and inform the design a future clinical trial suitable for assessing longer-term use in heart failure patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •At least 18 years of age.
- •If female, are postmenopausal or surgically sterilized, or have a negative pregnancy test within seven (7) days of invasive testing.
- •Advanced heart failure (NYHA Class III or IV)
排除标准
- •Hypotension treated with the following medications: epinephrine, norepinephrine, vasopressin, methylene blue, phenylephrine, or angiotensin II.
- •Receiving more than two inotropes.
- •Subclavian stenosis or stent.
- •Currently receiving circulatory support including ECMO, Impella, TandemLife or equivalents; or any durable VAD.
- •Atrial fibrillation without ventricular pacing.
- •Concomitant, non-cardiac disease process with life expectancy < 1 year.
- •Significant abnormalities of the aorta, such as aneurysms, coarctation of the aorta, or an extremely tortuous aorta.
- •Severe end-organ dysfunction or failure.
- •Any other condition the heart team believes inappropriate for this study.
结局指标
主要结局
Survival to transplant or stroke-free survival
时间窗: 30 days
次要结局
- Rate of occurrence of all adverse events(30 days)
- Rate of occurrence of procedure-related adverse events(30 days)
- Number of patients demonstrating improvement six minute walk test (6MWT) and two minute step test (2MST)(30 days)
- Number of patients who deteriorate requiring escalation of treatment(30 days)
- Rate of occurrence of serious device-related adverse events(30 days)
- Number of patients demonstrating improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) - quality of life (QOL)(30 days)
- Number of patients demonstrating improvement in Seattle Heart Failure Model Score(30 days)
- Number of patients demonstrating improvement in NYHA Classification(30 days)
研究者
研究点 (34)
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