NL-OMON40749招募中不适用
European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- corlife oHG
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •1. Indication for pulmonary valve replacement according to current medical guidelines in heart disease.
- •2. Informed consent of legal guardians or patients, assent of patients.
排除标准
- •1. The patient has not provided surveillance informed consent.
- •2. The patient shall not suffer from
- •a. generalized connective tissue disorders (eg, Marfan syndrome), or
- •b. active rheumatic disorders, or
- •c. severe asymmetric calcification of the valve ring.
- •3. The coronary arteries of the patient shall not be in abnormal position or heavily calcified.
- •4. Patients shall not show hypersensitivity against sodium dodecyl sulphate (SDS), sodium desoxycholate (SDC), human collagen (or other elastic fibers) or Benzonase®.
研究者
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