Surgery and Transcatheter Intervention for Structural Heart Diseases

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Data Collecting and Analyzing of Different Treatment of Structural Heart Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT02917980

XJ-20160829

Details and patient eligibility

About

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.

Full 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

Enrollment: 883 patients

Sex: All

Ages: 1 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

883 participants in 3 patient groups

surgical treatment

Description:

patients with structural heart disease received surgical treatment

interventional treatment

Description:

patients with structural heart disease received interventional treatment

surgical combined with interventional treatment

Description:

patients with structural heart disease received surgical combined with interventional treatment