Multicenter Registry Study of Surgery and Transcatheter Intervention for Structural Heart Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 883
- 试验地点
- 1
- 主要终点
- Death from any cause
研究概览
简要总结
This project aimed to optimize the therapeutic strategy for structural heart disease by choosing optimal treatment, such as,surgical treatment,interventional and surgery combined with interventional hybrid treatment. Thereby improve successful rate of clinical treatment, and establish the guideline for treatment of structural heart disease.At the same time,online registration database for structural heart disease will be established to further data analysis and objective assessment of clinical curative effect for structural heart disease in China.
详细描述
This project is a 5 years prospective,observational,longitudinal registration study on clinical surgical and interventional treatment of structural heart disease.Firstly,patients with structural heart disease, whom received surgical,interventional or surgery combined with interventional hybrid treatment during Jan. 2015 to Jan. 2020 ,were registrated dynamiclly. And further management and 1 year clinical follow-up,which contains demographic characteristics, clinical manifestations, treatment strategies and prognosis of outcome, were performed on the recruited data.Secondly, this is also a prospective observational study, featured by collecting data through annual follow-up,with the timing at the point of off the hospital,and 1,2,6,9,12 month after hospital discharge,respectively.
The inclusion criteria:
- atrial septal defect
- ventricular septal defect
- patent ductus arteriosis
- pulmonary stenosis
- residual leakage after surgical treatment for congenital heart disease
- coronary artery fistula
- pulmonary arteriovenous malformations
- tetralogy of Fallot, and other cyanotic heart disease
- mitral stenosis and insufficiency
- tricuspid stenosis and insufficiency
- aortic stenosis and insufficiency
- pulmonary stenosis and insufficiency
- coarctation of aorta
- paravalvular leakage
- hypertrophic obstructive heart disease
- dilated cardiomyopathy
- structural heart disease need surgery combined with interventional hybrid treatment
- structural heart disease need surgeryor interventional treatment
The exclusion criteria:
- primary arrhythmia cardiac disease,like tachycardia and ventricular fibrillation
- circulation disease, like coronary heart disease,hypertension,arterial aneurysm
- patients were not received any treatment
- patients were hard to follow-up
- no informed Consent
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.atrial septal defect 20ventricular septal defect 3.patent ductus arteriosis 4.pulmonary stenosis 5.residual leakage after surgical treatment for congenital heart disease 6.coronary artery fistula 7.pulmonary arteriovenous malformations 8.tetralogy of Fallot, and other cyanotic heart disease 9.mitral stenosis and insufficiency 10.tricuspid stenosis and insufficiency 11.aortic stenosis and insufficiency 12.pulmonary stenosis and insufficiency 13.coarctation of aorta 14.paravalvular leakage 15.hypertrophic obstructive heart disease 16.dilated cardiomyopathy 17.structural heart disease need surgery combined with interventional hybrid treatment 18.structural heart disease need surgeryor interventional treatment
排除标准
- •primary arrhythmia cardiac disease,like tachycardia and ventricular fibrillation
- •circulation disease, like coronary heart disease,hypertension,arterial aneurysm
- •patients were not received any treatment
- •patients were hard to follow-up
- •no informed Consent
结局指标
主要结局
Death from any cause
时间窗: 12 months
Cumulative MACE
时间窗: 12 months
Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)
次要结局
- residual shunt or regurgitation(12 months)
- cerebral incidence(12 months)
- hemolysis(12 months)
- Acute or chronic renal insufficiency(12 months)