Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT04980339 |
Other study ID # |
2021 ASO V1.0 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
October 1, 2022 |
Est. completion date |
October 31, 2032 |
Study information
Verified date |
July 2022 |
Source |
Wuhan Union Hospital, China |
Contact |
Li Zhang, PhD |
Phone |
18907131488 |
Email |
zli429[@]hust.edu.cn |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The aims of this study are to
1. Identify the early and midterm outcomes in terms of mortality and reoperation of the
arterial switch operation (ASO).
2. Identifying the influence of coronary artery anomalies on the in-hospital and
post-discharge prognosis after ASO.
3. Evaluate the predictors for neoaortic valve regurgitation after ASO.
4. Explore the risk factors for neopulmonary artery stenosis after ASO.
Description:
This study will enroll participants with transposition of the great arteries (TGA) and double
outlet right ventricle with subpulmonary ventricular septal defect (VSD) (Taussig-Bing
anomaly, TBA). The cardiac structure and function will be evaluated by multimodal imaging
including transthoracic echocardiographic examination, stress echocardiography, cardiac
computed tomography scan, cardiovascular magnetic resonance imaging.
And the study aimed to:
1. Identify the early and midterm outcomes in terms of mortality and reoperation of the
arterial switch operation (ASO) in participants with transposition of the great arteries
(TGA) and double outlet right ventricle with subpulmonary ventricular septal defect
(VSD) (Taussig-Bing anomaly, TBA).
2. Identifying subclinical coronary abnormalities and silent myocardial ischemia by
multimodel Imaging, further determine the influence of coronary artery anomalies on the
in-hospital and post-discharge prognosis in participants with TGA and TBA after ASO.
3. Evaluate the time course and predictors for neoaortic root dilatation and neoaortic
valve regurgitation in participants with TGA and TBA after ASO by multimodel Imaging.
4. Assess the structure of the right ventricular outflow tract and neopulmonary artery in
participants with TGA and TBA after ASO by multimodel Imaging, and explore the incidence
and risk factors for neopulmonary artery stenosis.