NCT02735993撤回不适用
Cardiac REgistry of Celution Device for the Processing of Adipose-derived Regenerative Cells: Treatment and Evaluation (CREATE)
Cytori Therapeutics0 个研究点开始时间: 2014年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Change in the Minnesota Living with Heart Failure Questionnaire.
研究概览
简要总结
This cardiac registry study will collect information from patients with ischemic or non-ischemic heart failure that have been treated with adipose-derived regenerative cells (ADRCs) delivered via intramyocardial injection.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females > 20 and < 80 years of age
- •Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization OR idiopathic dilated cardiomyopathy
- •Symptoms of heart failure (e.g. NYHA Stages of Heart Failure Class II or III)
- •On maximal medical therapy for heart failure and if present, anginal symptoms
- •Hemodynamic stability (SBP ≥ 90 mm/Hg, HR <110 beats/min)
- •Ejection fraction ≤ 45%
- •Left ventricular wall thickness > 5 mm at the target site(s) for cell injection, confirmed by Contrast Echo within 4 weeks prior to enrollment, and free of thrombus
排除标准
- •Vascular anatomy and/or peripheral artery disease that prevents or impedes cardiac catheterization
- •Aortic or mitral valve disease where valve replacement is indicated
- •Presence of mechanical aortic or mitral valves
- •Presence of aortic dissection
- •Planned staged treatment of CAD or other therapeutic intervention on the heart within the subsequent 3 months
- •TIA or stroke within 30 days prior to the procedure
- •ICD placement or ablation therapy within 30 days prior to the procedure
- •Acute coronary syndrome (ACS) or a myocardial infarction in the 30 days prior to the procedure
- •Revascularization within 30 days prior to intramyocardial injection of ADRCs
- •Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test at screening or baseline.
结局指标
主要结局
Change in the Minnesota Living with Heart Failure Questionnaire.
时间窗: 6 months
次要结局
- Angina Symptoms(Days 90, 180 and 360)
- Treadmill exercise test(Day 180)
- Heart Failure Symptoms(Days 90, 180 and 360)
- LVEF assessed by contrast Echocardiography(Day 180)
- LVESV/LVEDV(Day 180)
研究者
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