Register Zur Erhebung Von Langzeitergebnissen Nach Chirurgischem Aortenklappen Ersatz Mit Einer "Rapid Deployment" Aortenklappenprothese (Edwards Intuity) in Kombination Mit Einer Bypassoperation (CABG)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- all-cause mortality
研究概览
简要总结
This is a prospctive, unrandomized multicentric registry which will enrol patients with an indication for aortc valve replacement combined with myocardial reperfusion (CABG). The registry will collect patient specific baseline data and established risk scores (Logistic Euroscore I & II, STS-Score, KBA Score) to enable us to make an estimate about the perioperative risks.
详细描述
Aortic replacement combined with coronary bypass surgery has an impact on the risk profile for the direct postoperative course and also on the long-time survival perspective.
The advantage of rapid deployment aortic valve prostheses, like the Edward Intuity Elite Valve that is used in this registry, is the greater ease of implantation, because only a few sutures are necessary to secure the device compared to a conventional prosthesis, where more then ten sutures are needed. In procedures where the aortic valve replacement (AVR) is combined with a coronary artery bypass graft (CABG), the use of a rapid deployment valve can shorten the duration of cardiac ischemia and the overall intervention duration, which possibly has an influence on clinical results.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •patients with aortic valve stenosis and coronary heart disease with indication for AVR and CABG
- •patients in who the Edwards Intuity Elite valve is to be implanted
- •patients who are planned to receive at least one coronary bypass
- •patients who have signed an informed consent form
排除标准
- •Exclusion Criteria:
- •emergency surgery
- •re-operation (i.e. any previous opening of pericardium)
- •additional heart diseases requiring heart surgery (e. g. subvalvular myectomy and ablation, but not atrial auricle closure or resection)
- •legal incapacity or other circumstances that impair the patient's ability to understand the nature, meaning or extent of the trial
- •patients wanting a mechanical prosthesis
- •patients with contraindications for the Edwards Intuity Elite Valve
- •acute endocarditis or other systemic infections
结局指标
主要结局
all-cause mortality
时间窗: 30 Days
death from any reason
次要结局
未报告次要终点