Surgery and Transcatheter Intervention for Structural Heart Diseases

NCT ID: NCT02917980

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 883 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2022-12-31

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

Conditions

Data Collecting and Analyzing of Different Treatment of Structural Heart Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

surgical treatment

patients with structural heart disease received surgical treatment

No interventions assigned to this group

interventional treatment

patients with structural heart disease received interventional treatment

No interventions assigned to this group

surgical combined with interventional treatment

patients with structural heart disease received surgical combined with interventional treatment

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fu Wai Hospital, Beijing, China

OTHER

Sponsor Role: collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role: collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xijing Hospital

Xi'an, Shaan'xi Province, China

Countries

China

References

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Other Identifiers

XJ-20160829

Identifier Type: -

Identifier Source: org_study_id