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Clinical Trial Summary

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.


Clinical Trial Description

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: 1. atrial septal defect 2. ventricular 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 The exclusion criteria: 1. primary arrhythmia cardiac disease,like tachycardia and ventricular fibrillation 2. circulation disease, like coronary heart disease,hypertension,arterial aneurysm 3. patients were not received any treatment 4. patients were hard to follow-up 5. no informed Consent ;


Study Design


Related Conditions & MeSH terms

  • Data Collecting and Analyzing of Different Treatment of Structural Heart Diseases
  • Heart Diseases

NCT number NCT02917980
Study type Observational [Patient Registry]
Source Xijing Hospital
Contact
Status Completed
Phase
Start date January 2016
Completion date December 2022