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

Not yet recruiting

• Conditions: Arterial Switch Operation

• Registration Number: NCT04980339
• Lead Sponsor: Xie Mingxing

Brief 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.

Study Timeline

• Study First Submitted: 2021-07-10
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-07-28
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-13
• Study Start: 2022-10-01
• Primary Completion: 2032-10-31
• Study Completion: 2032-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause mortality	Ten years	Number of participants with all cause mortality after ASO

Secondary Outcome Measures

Name	Time	Method
Cardiac caused mortality	Ten years	Number of participants with cardiac caused mortality after ASO
All cause reoperation	Ten years	Number of participants with all cause reoperation after ASO
Right-ventricular outflow tract obstruction and pulmonary branch stenosis	Ten years	Degree of more than moderate right-ventricular outflow tract obstruction in millimetre of mercury, degree of pulmonary branch stenosis in millimetre of mercury
Neoaortic valve regurgitation	Ten years	Vena contracta width of neoaortic valve regurgitation in milimetre, ratio of Jet width/LVOT width in percentage