JPRN-UMIN000036550已完成3 期
A Prospective, Multi-Center, Single Arm Clinical Study to Evaluate the MDT-1118 Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure - MDT-1118 Japan DT Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1Patients with INTERMACS profile 1 2Existence of any ongoing mechanical circulatory support other than an intra-aortic balloon pump 3Prior cardiac transplant 4History of confirmed, untreated abdominal thoracic aortic aneurysm 5 cm, ventricular aneurysm or intraventricular septum rupture 5Severe calcification in thoracic aorta 6Cardiothoracic surgery within 14 days of implantation 7Acute myocardial infarction within 14 days of implant as diagnosed by ST or T wave changes on the ECG, diagnostic biomarkers, ongoing pain and hemodynamic abnormalities as described in the guidelines published in ACCAHA 2007 Guidelines for the Management of Patients with Unstable Angina NonSTElevation Myocardial Infarction1 8Patients eligible for cardiac transplantation 9On ventilator support for 72 hours within the four days immediately prior to implantation 10Pulmonary embolus within 21 days of implantation as documented by computed tomography scan or magnetic resonance imaging (MRI)
研究者
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