Multimodal Imaging Evaluation and Prognostic Analysis of Participants With Transposition of the Great Arteries After Arterial Switch Operation: a Multi-site Clinical Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arterial Switch Operation
- Sponsor
- Xie Mingxing
- Enrollment
- 1000
- Primary Endpoint
- All cause mortality
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The aims of this study are to
- Identify the early and midterm outcomes in terms of mortality and reoperation of the arterial switch operation (ASO).
- Identifying the influence of coronary artery anomalies on the in-hospital and post-discharge prognosis after ASO.
- Evaluate the predictors for neoaortic valve regurgitation after ASO.
- Explore the risk factors for neopulmonary artery stenosis after ASO.
Detailed 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.
Investigators
Xie Mingxing
Head of Department of Ultrasound, Union Hospital
Wuhan Union Hospital, China
Eligibility Criteria
Inclusion Criteria
- •·Participants with the diagnosis of TGA or TBA underwent ASO.
Exclusion Criteria
- •Patients with various forms of TGA undergoing Réparation à l'Etage Ventriculaire procedure
- •Patients with various forms of TGA undergoing Rastelli procedure
- •Patients with various forms of TGA undergoing Nikaidoh procedure
- •Patients with various forms of TGA undergoing Fontan operation
- •Patients with various forms of TGA undergoing atrial repair (Mustard or Senning) operations
- •ASO is used as a corrective therapy for prior operations.
Outcomes
Primary Outcomes
All cause mortality
Time Frame: Ten years
Number of participants with all cause mortality after ASO
Secondary Outcomes
- Cardiac caused mortality(Ten years)
- All cause reoperation(Ten years)
- Right-ventricular outflow tract obstruction and pulmonary branch stenosis(Ten years)
- Neoaortic valve regurgitation(Ten years)