Sutureless Closure for Primary Total Anomalous Pulmonary Venous Connection

NCT04938921 | Unknown

• 1 other identifier: 3685/QD-DHYD
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the percentage of pulmonary venous stenosis after TAPVC repair with sutureless closure.

Conditions

Total Anomalous Pulmonary Venous Connection; Pulmonary Venous Stenosis; Sutureless Closure

Keywords

TAPVC; Sutureless; Pulmonary venous stenosis

Outcome Measures

Primary Outcomes (3)

• The percentage of pulmonary venous stenosis after reparing TAPVC with sutureless technique

  The investigators calculate pulmonary venous score (PVS) based on the mean gradient through each pulmonary vein. Then we sum all the score of each pulmonary vein, range from 0 to 12, and classify to 4 levels. Score 0 if the mean gradient is less than 2mmHg, 1 if it is from 2 to 6,9mmHg, 2 if it is from 7 mmHg and above, and 3 if the vein is occluded. The degree of obstruction is classified as follow: none (0 to 1), mild (2 to 3), moderate (4 to 7), and severe (from 8 and above).

  The investigators assess the PVS at the time of 12 month after the operation.

• Early mortality (<30 days)

  Early mortality is defined when patients die within 30 days since the operation

  30 days

• The percentage of pulmonary venous stenosis after reparing TAPVC with sutureless technique

  The investigator calculate pulmonary venous score (PVS) based on the mean gradient through each pulmonary vein. Then we sum all the score of each pulmonary vein, range from 0 to 12, and classify to 4 levels. Score 0 if the mean gradient is less than 2mmHg, 1 if it is from 2 to 6,9mmHg, 2 if it is from 7 mmHg and above, and 3 if the vein is occluded. The degree of obstruction is classified as follow: none (0 to 1), mild (2 to 3), moderate (4 to 7), and severe (from 8 and above).

  The investigators assess the PVS at the time of 18 month after the operation.

Secondary Outcomes (2)

• Late mortality (> 30 days)

  The investigators assess mortality at the time of 18 month after the operation

• The percentage of pulmonary venous stenosis after reparing TAPVC with sutureless technique

  The investigators assess the PVS at the time of 6 month after the operation.

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All patients with TAPVC operated with sutureless closure and be agreed to joint this study by parents from 01/2019 to 06/2024

You may qualify if:

• All patients with TAPVC operated with sutureless closure and be agreed to join this study by parents from 01/2019 to 06/2024.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital 1: lead

Study Sites (1)

Children's Hospital 1

Ho Chi Minh City, 70000, Vietnam

RECRUITING

MeSH Terms

Conditions

Scimitar Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiratory System Abnormalities; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Thoi K Ngo, MSC

  Children's Hospital 1

  STUDY DIRECTOR

• Phuc M Vu, PhD

  University of Medicine and Pharmacy in HCMC

  STUDY DIRECTOR

• Tuan D Nguyen, MSC

  Children's Hospital 1

  STUDY DIRECTOR

• Linh NU Truong, PhD

  University of Medicine and Pharmacy in HCMC

  STUDY DIRECTOR

Central Study Contacts

Thanh QL Dinh, MSC

CONTACT

+84905911923; dql.thanh@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 25, 2021
• Study Start: May 30, 2019
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2024
• Last Updated: June 25, 2021

Record last verified: 2021-06

Locations

VN (1)