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Study on the application of improved patent ductus arteriosus closure intervention in the prevention and treatment of congenital heart disease in high-altitude areas

Study on the application of improved patent ductus arteriosus closure intervention in the prevention and treatment of congenital heart disease in high-altitude areas

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090901
Enrollment
Unknown
Registered
2024-10-15
Start date
2023-12-19
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

None

Interventions

Experimental group:PDA closure via femoral venipuncture without angiography under ultrasound guidance
Control group:PDA closure via femoral arteriovenous puncture under traditional descending aortography

Sponsors

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College Tibet Autonomous Region People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 63 Years

Inclusion criteria

Inclusion criteria: (1) Preoperative physical examination reveals Grade II to III systolic murmurs heard at the left sternal border in the 2nd to 3rd intercostal spaces; (2) Transthoracic echocardiography (TTE) indicates typical funnel-shaped patent ductus arteriosus (PDA) with clear visualization of PDA morphology and size under good acoustic window conditions.

Exclusion criteria

Exclusion criteria: (1) Patients with infective endocarditis or right-to-left shunt due to pulmonary hypertension; (2) Patients in combination with other cardiac defects requiring open surgery; (3) Patients with PDA-dependent heart defects.

Design outcomes

Primary

MeasureTime frame
24h complete plugging rate;success rate of operation;

Secondary

MeasureTime frame
fluoroscopy time;surgical radiation dose;intraoperative contrast dose;time of surgery;length of hospitalization;incidence of vascular complicatios;duration of bed confinement;preoperative and postoperative creatinine;preoperative and postoperative uric acid nitrogen;

Countries

China

Contacts

Public ContactHu Haibo

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

hhb.fwhospital@hotmail.com+86 133 6645 8604

Outcome results

None listed

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