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

Xie Mingxing

Status: Not yet enrolling

Conditions: Arterial Switch Operation

Study type: Observational

Funder types: Other

Identifiers

NCT04980339

2021 ASO V1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

ASO group

Description:

All participants with TGA/TBA after ASO