Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT04980339

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Arterial Switch Operation

Sex eligibility

All sexes

Study type

Observational

About this study

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:

  • 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).
  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. All cause mortality

    Time frame: Ten years

    Number of participants with all cause mortality after ASO

Secondary outcomes

  1. Cardiac caused mortality

    Time frame: Ten years

    Number of participants with cardiac caused mortality after ASO

  2. All cause reoperation

    Time frame: Ten years

    Number of participants with all cause reoperation after ASO

  3. Right-ventricular outflow tract obstruction and pulmonary branch stenosis

    Time frame: 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

  4. Neoaortic valve regurgitation

    Time frame: Ten years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Li Zhang, PhD

CONTACT

[email protected]

18907131488

Sponsors and collaborators

Lead sponsor

Xie Mingxing

Other

Collaborators

  • Guangdong Provincial People's Hospital
  • Henan Provincial People's Hospital
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Shanghai Zhongshan Hospital
  • Wuhan Asia Heart Hospital

Registry information

Official study title

Multimodal Imaging Evaluation and Prognostic Analysis of Participants With Transposition of the Great Arteries After Arterial Switch Operation: a Multi-site Clinical Study

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Jul 28, 2021
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.