Database on Ross Operation Failures and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Quality of life-1
研究概览
简要总结
A large multicentric registry to obtain data to analyse the pulmonary autograft (PA) failure phenomenon and feed more complex biomechanical models to be integrated with clinical imaging with the final aim to predict Ross operation's outcomes and define strategies to ameliorate its results.
详细描述
On the basis of the current knowledge on the outcomes of Ross Operation we aim to create a large multi centric registry in order to obtain data on the preoperative intraoperative management of these patients and on the postoperative long-term results of this procedure.
Patients data will be entered by the investigators in an electronic database Preoperative variables will include age, comorbidities, functional status, indications for surgery, morphology of the aortic valve Additional morphological data and aortic and pulmonary measurements will be taken intraoperatively Postoperative follow-up data including both clinical outcomes (mortality, reoperation for pulmonary autograft failure, major cardiac events, stroke, infection) and morphological measurements by means of CT scan or echocardiography, will be inserted.
Quality of life by means of SF12 and Minnesota living with heart failure questionnaire and EQ-5D score will be collected.
Follow-up endpoints are at discharge, 1 year 5 years 10 years 15 years and 20 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 1 Day 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergone (or undergoing) to Ross Operation
排除标准
- •Patients requiring combined cardiac surgical procedure in association to Ross Operation
结局指标
主要结局
Quality of life-1
时间窗: from inclusion to 20 years follow-up
Quality of life as measured with SF-12
Cardiac Death
时间窗: from inclusion to 20 years follow-up
Mortality due to cardiac cause
Reoperation for Pulmonary Autograft Failure
时间窗: from inclusion to 20 years follow-up
Need for reoperation due to failure of pulmonary autograft or valve degeneration
Rehospitalization for heart failure
时间窗: from inclusion to 20 years follow-up
Readmission to hospital for heart failure
Survival
时间窗: from inclusion to 20 years follow-up
Death from any cause
Stroke
时间窗: from inclusion to 20 years follow-up
neurological stroke with impairment
Quality of life-2
时间窗: from inclusion to 20 years follow-up
Quality of life as measured with Minnesota living with heart failure questionnaire
Quality of life-3
时间窗: from inclusion to 20 years follow-up
Quality of life as measured withEQ 5D score
次要结局
- Postoperative complications(postoperative period (1-30 days))