Aortic Replacement Using Individualised Regenerative Allografts: Bridging the Therapeutic Gap - ARISE (the "Surveillance")
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- corlife
- 入组人数
- 144
- 试验地点
- 8
- 主要终点
- Freedom from valve dysfunction at end of the study
研究概览
简要总结
Evaluation of decellularized human heart valves for aortic 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.
详细描述
This is a prospective, non-randomized, single-arm, multi-centre surveillance study to be conducted in Europe.
The Surveillance is designed as a study, where
- ARISE AV is prescribed in the usual manner in accordance with the terms of the approval.
- 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 ARISE AV 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.
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
- •i. Indication for aortic valve replacement according to current medical guidelines in valvular heart disease
- •ii. Informed consent of legal guardians or patients, assent of patients
排除标准
- •i. The patient has not provided Surveillance informed consent.
- •ii. 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.
- •iii. The coronary arteries of the patient shall not be in abnormal position or heavily calcified.
- •iv. 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
Freedom from valve dysfunction at end of the study
时间窗: up to 24 months
Echocardiographic studies should be obtained and analyzed at discharge and at 3, 6 Months and at annual follow-ups. The requested variables include peak and mean systolic gradient, using pw and cw doppler, in the left ventricular outflow tract, respective the aortic valve. The echo evaluation (videotape or CD) should remain at the Surveillance site, but be available to corlife Surveillance personnel upon request. The MRIs will be analyzed by the MRI Core Laboratory at Medical School in Hannover for potential valvular stenosis, via phase contrast flow measurements in the aorta and for valvular competence, via phase contrast flow measurements and by ventricular volumetry. MRI cine images will be used to visualize the Surveillance valve in patients with poor echocardiographic windows.
Cardiovascular Adverse Reactions (AR)
时间窗: up to 24 months
Rate of cardiovascular AR, e.g. all-cause mortality, major stroke, life-threatening (or disabling) bleeding, acute kidney injury-stage 3 (including renal replacement therapy), peri-procedural myocardial infarction, major vascular complication, repeat procedure for valve-related dysfunction (surgical or interventional therapy).
次要结局
- Evaluation of composite valve measures(up to 24 months)
- Evaluation of composite blood parameters(up to 24 months)
- Time to reoperation and / or death(up to 24 months)