Surgery and Transcatheter Intervention for Structural Heart Diseases

Completed

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

• Registration Number: NCT02917980
• Lead Sponsor: Xijing Hospital

Brief 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.

Detailed 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 Timeline

• Study Start: 2016-01
• Status Verified: 2016-09
• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-28
• Primary Completion: 2020-01
• Study Completion: 2022-12
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 883

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death from any cause	12 months
Cumulative MACE	12 months	Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)

Secondary Outcome Measures

Name	Time	Method
residual shunt or regurgitation	12 months
cerebral incidence	12 months
hemolysis	12 months
Acute or chronic renal insufficiency	12 months

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China