Surgery and Transcatheter Intervention for Structural Hea... | NCT02917980

Studies
Surgery and Transcatheter Intervention for Structural Heart Diseases

NCT02917980

Sponsor

Xijing Hospital

Status

Completed

Last Update Posted

Jan 11, 2023Actual

Enrollment

883Actual

Phase

Not provided

Conditions

Data Collecting and Analyzing of Different Treatment of Structural Heart Diseases

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Jan 2020Actual

Completion Date

Dec 2022Actual

First Submitted Date

Sep 27, 2016

First Submission Date that Met QC Criteria

Sep 27, 2016

First Posted Date

Sep 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2023

Last Update Posted Date

Jan 11, 2023Actual

Name	Class
Fu Wai Hospital, Beijing, China	OTHER
Beijing Anzhen Hospital	OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

atrial septal defect
ventricular septal defect
patent ductus arteriosis
pulmonary stenosis
residual leakage after surgical treatment for congenital heart disease
coronary artery fistula
pulmonary arteriovenous malformations
tetralogy of Fallot, and other cyanotic heart disease
mitral stenosis and insufficiency
tricuspid stenosis and insufficiency
aortic stenosis and insufficiency
pulmonary stenosis and insufficiency
coarctation of aorta
paravalvular leakage
hypertrophic obstructive heart disease
dilated cardiomyopathy
structural heart disease need surgery combined with interventional hybrid treatment
structural heart disease need surgeryor interventional treatment

The exclusion criteria:

primary arrhythmia cardiac disease,like tachycardia and ventricular fibrillation
circulation disease, like coronary heart disease,hypertension,arterial aneurysm
patients were not received any treatment
patients were hard to follow-up
no informed Consent

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

883Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
surgical treatment		patients with structural heart disease received surgical treatment
interventional treatment		patients with structural heart disease received interventional treatment
surgical combined with interventional treatment		patients with structural heart disease received surgical combined with interventional treatment

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Acute or chronic renal insufficiency		12 months
residual shunt or regurgitation		12 months
cerebral incidence

Other Outcomes

Not provided

Eligibility Module

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:

primary arrhythmia cardiac disease,like tachycardia and ventricular fibrillation
circulation disease, like coronary heart disease,hypertension,arterial aneurysm
patients were not received any treatment
patients were hard to follow-up
no informed Consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with structural heart disease, whom received surgical,interventional or surgery combined with interventional hybrid treatment

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Xijing Hospital		Xi'an	Shaan'xi Province	710032	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41088494	Derived	Mao Y, Liu Y, Zhai M, Jin P, Chen F, Yang Y, Zhang G, Shang X, Jian Z, Zhang H, Wei L, Liu J, Guo Y, Pan X, Wu Y, Piazza N, Yang J. Treatment options for young patients with asymptomatic severe aortic stenosis: a multicenter retrospective cohort study. Eur J Med Res. 2025 Oct 14;30(1):966. doi: 10.1186/s40001-025-03227-6.
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