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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04980339
Enrollment
1000
Registered
2021-07-28
Start date
2022-10-01
Completion date
2032-10-31
Last updated
2022-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Switch Operation

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.

Interventions

None listed

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
CollaboratorOTHER
Shanghai Zhongshan Hospital
CollaboratorOTHER
Henan Provincial People's Hospital
CollaboratorOTHER
Wuhan Asia Heart Hospital
CollaboratorOTHER
Guangdong Provincial People's Hospital
CollaboratorOTHER
Xie Mingxing
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
All cause mortalityTen yearsNumber of participants with all cause mortality after ASO

Secondary

MeasureTime frameDescription
Cardiac caused mortalityTen yearsNumber of participants with cardiac caused mortality after ASO
All cause reoperationTen yearsNumber of participants with all cause reoperation after ASO
Right-ventricular outflow tract obstruction and pulmonary branch stenosisTen yearsDegree of more than moderate right-ventricular outflow tract obstruction in millimetre of mercury, degree of pulmonary branch stenosis in millimetre of mercury
Neoaortic valve regurgitationTen yearsVena contracta width of neoaortic valve regurgitation in milimetre, ratio of Jet width/LVOT width in percentage

Contacts

Primary ContactLi Zhang, PhD
zli429@hust.edu.cn18907131488

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026