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

N/ANot Yet RecruitingNCT04980339

Xie Mingxing1,000 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Arterial Switch Operation

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Number of participants with all cause mortality after ASO

Time frame: Ten years

Secondary Outcomes

Cardiac caused mortality

Number of participants with cardiac caused mortality after ASO

Time frame: Ten years

All cause reoperation

Number of participants with all cause reoperation after ASO

Time frame: Ten years

Right-ventricular outflow tract obstruction and pulmonary branch stenosis

Degree of more than moderate right-ventricular outflow tract obstruction in millimetre of mercury, degree of pulmonary branch stenosis in millimetre of mercury

Time frame: Ten years

Neoaortic valve regurgitation

Vena contracta width of neoaortic valve regurgitation in milimetre, ratio of Jet width/LVOT width in percentage

Time frame: Ten years

Central Contacts

Li Zhang, PhD

CONTACT

18907131488 zli429@hust.edu.cn

Data from ClinicalTrials.gov

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