Outcomes of Transposition of the Great Arteries After Arterial Switch Operation

NCT05089773 | Completed

• 1 other identifier: TGA-CTS
• Study Type: observational
• Target: 1,281
• Locations: 1 country
• Sites: 2

Brief Summary

Transposition of the great arteries (TGA) is a complex cyanotic congenital heart disease and patients suffer from a high mortality rate within one year of age without appropriate management. The therapeutic effect of arterial switch operation (ASO) is satisfactory with low surgery mortality of 2-5%, and thus, has become the treatment of choice for surgical correction of d-TGA. Outcomes of ASO in TGA in china are rare. This is a retrospective study reporting the outcomes of ASO in TGA.

Conditions

Transposition of Great Vessels; Outcome, Fatal

Keywords

arterial switch operation; late referral; transposition of the great arteries

Outcome Measures

Primary Outcomes (3)

• hospital mortality

  death occurred within the hospital

  within 1 month after ASO

• late death

  death occurred after discharge

  after 1 month after ASO

• redo operation

  reintervention after the ASO procedure

  through study completion, an average of 10 year

Study Arms (1)

group 1

The only group in this retrospective study includes patients diagnosed with transposition of the great arteries receiving arterial switch operation in children's hospital of fudan university and shanghai children's medical center.

Procedure: The arterial switch operation

Interventions

The arterial switch operation PROCEDURE

The ASO is a procedure that emerged as an anatomically as well as physiologically appropriate solution to the transposition of the great arteries. The aorta and pulmonary artery are detached from their native roots and reattached to the opposite root; thus, the pulmonary root becomes the neo-aorta, and the aortic root becomes the neo-pulmonary artery. The coronary arteries are transplanted from the aorta/neo-pulmonary artery to the pulmonary artery/neo-aorta.

group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with the great arteries receiving the arterial switch operation in children's hospital of Fudan university and Shanghai children's medical center from January 2000 to March 2020, regardless of the age, sex, and the anatomy.

You may qualify if:

• Patients diagnosed with the great arteries receiving the arterial switch operation in children's hospital of Fudan university and Shanghai children's medical center from January 2000 to March 2020.

You may not qualify if:

• NA.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Shanghai Children's Medical Center: collaborator

Study Sites (2)

Children's Hospital of Fudan University

Shanghai, 200000, China

Location

Shanghai Children's medical center

Shanghai, China

Location

MeSH Terms

Conditions

Transposition of Great Vessels

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Bing Jia, MD, PhD

  Children's Hospital of Fudan University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: October 22, 2021
• Study Start: December 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: April 30, 2020
• Last Updated: October 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)