Feasibility and Comparison of the Impact of Different Frailty Assessment Tools on the Outcome of Ventricular Assist Device Implantation and Heart Transplantation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Incidence of not performed tests due to clinical concerns/inability of the patient (feasibility and safety)
研究概览
简要总结
Feasibility and Comparison of the Impact of different Frailty Assessment Tools on the Outcome of Ventricular Assist Device Implantation and Heart Transplantation in advanced heart failure patients
详细描述
Comparison of the feasibility and results of the following frailty assessment tools in advanced heart failure patients treated with ventricular assist device Implantation or awaiting heart transplantation in Eurotransplant-Status "high urgency":
- Evaluation of the muscle mass in the preoperative CT-Scan
- Bioelectrical Impedance Analysis
- 6 Minute Walk Test
- Grip Strength Measurement
- Questionnaires: EQ5D-5L, Rockwood Frailty Scale
The assessment will be conducted prior to surgery, after surgery and at 6 Month Follow-up
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Planned VAD Implantation/ HU-Status awaiting Heart Transplantation
- •Signature on Informed Consent
排除标准
- •< 18 years old
- •Informed consent not possible/not signed
- •Pregnancy/Breastfeeding
结局指标
主要结局
Incidence of not performed tests due to clinical concerns/inability of the patient (feasibility and safety)
时间窗: 6 Month Follow-up
Number of patients, who were not able to perform tests and reasons
Impact of frailty estimated by the different frailty assessment tools on the outcome 6 month mortality and/or prolonged ventilation time
时间窗: After 6 Month
Combined Endpoint: Endpoint is met if the Patient dies within 6 month after surgery and/or needed of a prolonged ventilation time of \>95h during the ICU stay after surgery
次要结局
未报告次要终点