European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- corlife
- 入组人数
- 121
- 试验地点
- 8
- 主要终点
- Amount of SARs (serious adverse reactions)
研究概览
简要总结
This is a prospective, non-randomized, single-arm, multicentre surveillance study to be conducted in Europe. The Surveillance is designed as a study, where
- ESPOIR pulmonary valve (PV) is prescribed in the usual manner in accordance with the terms of the approval.
- The assignment of the patient to a particular therapeutic strategy is not decided in advance by this Surveillance Protocol but falls within current practice and the prescription of ESPOIR PV is clearly separated from the decision to include the patient in the Surveillance.
- No additional diagnostic or monitoring procedures shall be applied to the patients
- and epidemiological methods shall be used for the analysis of collected data.
Evaluation of decellularized human heart valves for pulmonary heart valve replacement in comparison to current valve substitutes. Safety endpoints include cardiovascular adverse events, time to re-operation, re-intervention and explantation. Efficacy endpoints include freedom from valve dysfunction and hemodynamic performance.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for pulmonary valve replacement according to current medical guidelines in heart disease.
- •Signed Informed consent of legal guardians or patients, assent of patients.
排除标准
- •The patient has not provided Surveillance informed consent.
- •The patient shall not suffer from
- •generalized connective tissue disorders (eg, Marfan syndrome), or
- •active rheumatic disorders, or
- •severe asymmetric calcification of the valve ring.
- •The coronary arteries of the patient shall not be in abnormal position or heavily calcified.
- •Patients shall not show hypersensitivity against Sodium Dodecyl Sulphate (SDS), Sodium Desoxycholate (SDC), human collagen (or other elastic fibers) or Benzonase®.
结局指标
主要结局
Amount of SARs (serious adverse reactions)
时间窗: up to 24 months
Cardiovascular Adverse Reactions; Serious Adverse Reactions, such as infections, immunological reactions, etc.
Freedom from valve dysfunction
时间窗: up to 24 months
Freedom from valve dysfunction leading to re-intervention or explantation at end of the study.
次要结局
- Time to death(up to 24 months)
- Blood Parameters(up to 24 months)
- Evaluation of transvalvular gradients(up to 24 months)
- Diameters of ESPOIR PV at end of the study(after 24 months)
- Time to reoperation(up to to 24 months)