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A Single-center Retrospective Study to Verify the Diagnostic Value of Systematic Seven-step Pediatric Echocardiography in Simple Congenital Heart Diseases

A Single-center Retrospective Study to Verify the Diagnostic Value of Systematic Seven-step Pediatric Echocardiography in Simple Congenital Heart Diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116768
Enrollment
Unknown
Registered
2026-01-14
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Simple congenital heart disease

Interventions

Gold Standard:Intraoperative direct visualization measurement and description are regarded as the gold standard for assessing the size and location of defects. For interventional treatment of PDA and
Index test:Seven-Step Method for Pediatric Echocardiography

Sponsors

Children's Hospital,Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: Pediatric patients aged <= 18 years old;.who underwent a complete transthoracic echocardiography (TTE) examination in our hospital with complete storage of both imaging and textual data;and were finally diagnosed with isolated atrial septal defect (ASD), ventricular septal defect (VSD), patent ductus arteriosus (PDA), patent foramen ovale (PFO), or simple combinations of the above conditions via surgical operation or interventional therapy (with surgical findings or measurements from transesophageal echocardiography (TEE) and angiography during interventional therapy as the gold standard), with complete electronic medical records and surgical documentation.

Exclusion criteria

Exclusion criteria: Complicated with other complex cardiac malformations (such as tetralogy of Fallot, transposition of the great arteries, etc.) or severe malformations in other systems (such as pectus carinatum, severe pulmonary diseases, etc.);poor image quality that prevents retrospective analysis using the seven-step method;.lack of accurate data from surgical/interventional measurements or a history of prior surgical/interventional treatment.

Design outcomes

Primary

MeasureTime frame
Bias;Accuracy;Sensitivity;Specificity;Operation success rate;Overall completion rate;

Secondary

MeasureTime frame
Kappa coefficient;Pearson Correlation Analysis;ICC;ROC-AUC;

Countries

China

Contacts

Public ContactJiang ying

Children's Hospital,Zhejiang University School of Medicine

1249049839@qq.com+86 571 8706 1007

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026