Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02917980 |
Other study ID # |
XJ-20160829 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 2016 |
Est. completion date |
December 2022 |
Study information
Verified date |
September 2016 |
Source |
Xijing Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
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.
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