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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 July 2021 |
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Main ID: |
NCT04938921 |
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Date of registration:
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16/06/2021 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Sutureless Closure for Primary Total Anomalous Pulmonary Venous Connection
TAPVC |
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Scientific title:
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Short-term and Mid-term Outcome of Sutureless Closure for Primary Total Anomalous Pulmonary Venous Connection |
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Date of first enrolment:
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May 30, 2019 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04938921 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Vietnam
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Contacts
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Name:
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Thanh QL Dinh, MSC |
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Address:
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Telephone:
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+84905911923 |
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Email:
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dql.thanh@gmail.com |
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Affiliation:
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Name:
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Thanh QL Dinh, MSC |
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Address:
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Telephone:
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+84905911923 |
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Email:
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dql.thanh@gmail.com |
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Affiliation:
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Name:
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Thoi K Ngo, MSC |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital 1 |
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Name:
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Tuan D Nguyen, MSC |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital 1 |
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Name:
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Linh NU Truong, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Medicine and Pharmacy in HCMC |
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Name:
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Phuc M Vu, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Medicine and Pharmacy in HCMC |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients with TAPVC operated with sutureless closure and be agreed to join this
study by parents from 01/2019 to 06/2024.
Exclusion Criteria:
- TAPVC operated with sutureless closure have single ventricle, isomerism or heterotaxy,
congenital pulmonary venous stenosis.
- TAPVC enrolled to study but cannot the obtain the echocardiography at the time of 1
month, 6 month, 12 month and 18 month.
Age minimum:
N/A
Age maximum:
15 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Venous Stenosis
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Sutureless Closure
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Total Anomalous Pulmonary Venous Connection
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Primary Outcome(s)
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Early mortality (<30 days)
[Time Frame: 30 days]
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The percentage of pulmonary venous stenosis after reparing TAPVC with sutureless technique
[Time Frame: The investigators assess the PVS at the time of 12 month after the operation.]
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The percentage of pulmonary venous stenosis after reparing TAPVC with sutureless technique
[Time Frame: The investigators assess the PVS at the time of 18 month after the operation.]
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Secondary Outcome(s)
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Late mortality (> 30 days)
[Time Frame: The investigators assess mortality at the time of 18 month after the operation]
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The percentage of pulmonary venous stenosis after reparing TAPVC with sutureless technique
[Time Frame: The investigators assess the PVS at the time of 6 month after the operation.]
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Secondary ID(s)
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3685/QD-DHYD
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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