Multimodal Imaging Evaluation and Prognostic Analysis of Participants After Arterial Switch Operation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Arterial Switch Operation. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multimodal Imaging Evaluation and Prognostic Analysis of Participants With Transposition of the Great Arteries After Arterial Switch Operation: a Multi-site Clinical Study
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.
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.
Primary outcome measures
- All cause mortality [Time frame: Ten years]
Secondary outcome measures (4)
- Cardiac caused mortality [Time frame: Ten years]
- All cause reoperation [Time frame: Ten years]
- Right-ventricular outflow tract obstruction and pulmonary branch stenosis [Time frame: Ten years]
- Neoaortic valve regurgitation [Time frame: Ten years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04980339 · 2021 ASO V1.0