Surgery and Transcatheter Intervention for Structural Heart Diseases

Data Collecting and Analyzing of Different Treatment of Structural Heart Diseases Clinical Trial

Official title:

Multicenter Registry Study of Surgery and Transcatheter Intervention for Structural Heart Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02917980
• Other study ID #: XJ-20160829
• Status: Completed
• 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
• 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 883
• Est. completion date: December 2022
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (4)

Lead Sponsor	Collaborator
Xijing Hospital	Beijing Anzhen Hospital, Fu Wai Hospital, Beijing, China, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death from any cause		12 months
Primary	Cumulative MACE	Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)	12 months
Secondary	Acute or chronic renal insufficiency		12 months
Secondary	residual shunt or regurgitation		12 months
Secondary	cerebral incidence		12 months
Secondary	hemolysis		12 months