Sutureless Closure for Primary Total Anomalous Pulmonary Venous Connection

• Conditions: Total Anomalous Pulmonary Venous Connection; Pulmonary Venous Stenosis; Sutureless Closure

• Registration Number: NCT04938921
• Lead Sponsor: Children's Hospital 1

Brief Summary

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

Detailed Description

Parents of patients with TAPVC after repairing by sutureless technique will be informed about the study. If parents agree to participant in the study and sign the informed consent, the investigators will collect information of patients and echocardiography results at 1 month, 6 month, 12 month and 18 month after the operation.

Study Timeline

• Study Start: 2019-05-30
• Status Verified: 2021-06
• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-06-23
• Last Update Submitted: 2021-06-23
• Study First Posted: 2021-06-25
• Last Update Posted: 2021-06-25
• Primary Completion: 2022-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of pulmonary venous stenosis after reparing TAPVC with sutureless technique	The investigators assess the PVS at the time of 18 month after the operation.	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).
Early mortality (<30 days)	30 days	Early mortality is defined when patients die within 30 days since the operation

Secondary Outcome Measures

Name	Time	Method
Late mortality (> 30 days)	The investigators assess mortality at the time of 18 month after the operation	Late mortality is defined when patients die beyond 30 day since 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.	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).

Trial Locations

Locations (1)

Children's Hospital 1; 🇻🇳 Ho Chi Minh City, Vietnam