NCT04980339

Multimodal Imaging Evaluation and Prognostic Analysis of Participants After Arterial Switch Operation

Multimodal Imaging Evaluation and Prognostic Analysis of Participants With Transposition of the Great Arteries After Arterial Switch Operation: a Multi-site Clinical Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Xie Mingxing · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Arterial Switch Operation

Timeline

• Start date: 2022-10-01
• Primary completion: 2032-10-31
• Completion: 2032-10-31
• First posted: 2021-07-28
• Last updated: 2022-07-13