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An Observational Registry Study of Clinical Characteristics and Prognosis in Congenital Heart Disease with Aortic Root Lesions Using Echocardiography

An Observational Registry Study of Clinical Characteristics and Prognosis in Congenital Heart Disease with Aortic Root Lesions Using Echocardiography

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600127985
Enrollment
Unknown
Registered
2026-07-11
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Congenital heart disease encompasses ventricular septal defect, atrial septal defect, patent ductus arteriosus, tetralogy of Fallot, double outlet right ventricle, transposition of the great arteries, persistent arterial trunk, endocardial cushion defect, single ventricle, and Ebstein anomaly

Interventions

case series:None

Sponsors

The Second Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Congenital heart diseases include ventricular septal defect (VSD), atrial septal defect (ASD), patent ductus arteriosus (PDA), tetralogy of Fallot (TOF), double outlet right ventricle (DORV), transposition of the great arteries (TGA), persistent arterial trunk (TA), pulmonary stenosis (PS), endocardial cushion defect (ECD), single ventricle (SV), and Ebstein anomaly. 2. Aortic root pathologies include aortic sinus aneurysm (ruptured or unruptured), bicuspid aortic valve, aortic valve prolapse, aortic root dilation or aneurysm (Z-score >= 2), Type A aortic dissection involving the root, infective endocarditis-induced aortic root abscess or perivalvular leakage, Marfan syndrome, and other related conditions. 3. Mixed or joint pathologies are also encountered. These include aortic sinus aneurysm rupture complicated by ventricular septal defect, aortic sinus aneurysm rupture combined with aortic valve prolapse or a bicuspid aortic valve, and bicuspid aortic valve with concomitant aortic root dilation. 4. Ultrasound images are complete and traceable, with ultrasound report completeness =80% (for retrospective data).

Exclusion criteria

Exclusion criteria: 1.Isolated coronary artery disease, cardiomyopathy, pericardial diseases, cardiac tumors (excluding CHD or ARD); 2.The ultrasound image quality is poor, making it impossible to measure key parameters; 3.Clinical data missing; 4.Patients or legal guardians who explicitly refuse data use for research or are unable to complete follow-up (applicable only to the prospective component).

Design outcomes

Primary

MeasureTime frame
Primary composite endpoint (All-cause mortality, heart transplantation, reoperation/interventional therapy, hospitalization for heart failure, infective endocarditis, aortic diss);

Secondary

MeasureTime frame
Secondary endpoints: NYHA worsening =1 class, new-onset arrhythmia, pulmonary hypertension progression, echocardiographic parameter deterioration.;

Countries

China

Contacts

Public ContactChen Rong

The Second Affiliated Hospital of Xi'an Jiaotong University

Puffchen0702@163.com+86 29 87679424

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026