NCT04980339

Brief Summary

The aims of this study are to

  1. 1.Identify the early and midterm outcomes in terms of mortality and reoperation of the arterial switch operation (ASO).
  2. 2.Identifying the influence of coronary artery anomalies on the in-hospital and post-discharge prognosis after ASO.
  3. 3.Evaluate the predictors for neoaortic valve regurgitation after ASO.
  4. 4.Explore the risk factors for neopulmonary artery stenosis after ASO.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
79mo left

Started Oct 2022

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Oct 2022Oct 2032

First Submitted

Initial submission to the registry

July 10, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2032

Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

10.1 years

First QC Date

July 10, 2021

Last Update Submit

July 12, 2022

Conditions

Arterial Switch Operation

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    Number of participants with all cause mortality after ASO

    Ten years

Secondary Outcomes (4)

  • Cardiac caused mortality

    Ten years

  • All cause reoperation

    Ten years

  • Right-ventricular outflow tract obstruction and pulmonary branch stenosis

    Ten years

  • Neoaortic valve regurgitation

    Ten years

Study Arms (1)

ASO group

All participants with TGA/TBA after ASO

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All participants diagnosed with TGA or TBA underwent ASO in the hospital with an eligible cardiovascular surgery center.

You may qualify if:

  • ·Participants with the diagnosis of TGA or TBA underwent ASO.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Li Zhang, PhD

    Department of Ultrasound, Union Hospital, Wuhan, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Zhang, PhD

CONTACT

18907131488zli429@hust.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Department of Ultrasound, Union Hospital

Study Record Dates

First Submitted

July 10, 2021

First Posted

July 28, 2021

Study Start

October 1, 2022

Primary Completion (Estimated)

October 31, 2032

Study Completion (Estimated)

October 31, 2032

Last Updated

July 13, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share