NCT05089773|Completed
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Sponsor study identifier
observational
1,281
1 country
2
Study Start
December 1, 2019
Actual (reported)Primary Completion
March 30, 2020
Actual (reported)Study Completion
April 30, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2020
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 1, 2019
Actual (reported)March 30, 2020
Actual (reported)April 30, 2020
Actual (reported)March 10, 2021
Actual (reported)October 22, 2021
Actual (reported)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
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.
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.
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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.
Children's Hospital of Fudan University
Shanghai, 200000, China
Shanghai Children's medical center
Shanghai, China
Bing Jia, MD, PhD
Children's Hospital of Fudan University
1,281 participants (actual enrollment reported by the registry).
First Submitted
March 10, 2021
First Posted
October 22, 2021
Study Start
December 1, 2019
Actual (reported)Late Function After Surgery for Transposition of the Great Arteries
Contact the study team to confirm eligibility.
Primary Completion
March 30, 2020
Actual (reported)Study Completion
April 30, 2020
Actual (reported)Last Updated
October 22, 2021
Record last verified: 2021-03
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Source: ClinicalTrials.gov.
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