Clinical trial NCT02917980: Surgery and Transcatheter Intervention for Structural Heart Diseases
Official title: Multicenter Registry Study of Surgery and Transcatheter Intervention for Structural Heart Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Data Collecting and Analyzing of Different Treatment of Structural Heart Diseases
Keywords: structural Heart Diseases
surgical treatment
interventional treatment
hybrid treatment
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Fu Wai Hospital, Beijing, China
name: Beijing Anzhen Hospital
name: Wuhan Union Hospital, China
First posted: 2016-09-28
Enrollment: 883
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with structural heart disease, whom received surgical,interventional or surgery combined with interventional hybrid treatment

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

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

Primary outcomes:
measure: Death from any cause
timeFrame: 12 months
measure: Cumulative MACE
timeFrame: 12 months
Secondary outcomes:
measure: Acute or chronic renal insufficiency
timeFrame: 12 months
measure: residual shunt or regurgitation
timeFrame: 12 months
measure: cerebral incidence
timeFrame: 12 months
measure: hemolysis
timeFrame: 12 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
References:
citation: Liu Y, Zhai M, Mao Y, Xu C, Ma Y, Li L, Jin P, Yang J. Transcatheter aortic valve replacement in patients with quadricuspid aortic valve in a single center. Front Cardiovasc Med. 2022 Sep 28;9:1011466. doi: 10.3389/fcvm.2022.1011466. eCollection 2022.
citation: Mao Y, Liu Y, Ma Y, Jin P, Li L, Yang J. Mitral Valve-in-Valve Implant of a Balloon-Expandable Valve Guided by 3-Dimensional Printing. Front Cardiovasc Med. 2022 May 30;9:894160. doi: 10.3389/fcvm.2022.894160. eCollection 2022.
citation: Xu C, Liu Y, Zhai M, Jin P, Li L, Ma Y, Yang J. Transcatheter Closure of a Paravalvular Leak Guided by Transesophageal Echocardiography and Three-Dimensional Printing. Front Cardiovasc Med. 2022 May 20;9:750896. doi: 10.3389/fcvm.2022.750896. eCollection 2022.
citation: Ding P, Xu C, Liu Y, Meng X, Jin P, Tang J, Li L, Ma Y, Yang J. Application of three-dimensional transesophageal echocardiography in preoperative evaluation of transcatheter aortic valve replacement. BMC Cardiovasc Disord. 2021 Jun 28;21(1):315. doi: 10.1186/s12872-021-02101-7.
citation: Liu Y, Xu C, Ding P, Tang J, Jin P, Li L, Chen M, Meng X, Zhao H, Yang J. Transcatheter Closure of Mitral Paravalvular Leak via Multiple Approaches. J Interv Cardiol. 2021 Mar 2;2021:6630774. doi: 10.1155/2021/6630774. eCollection 2021.