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Sutureless Closure for Primary Total Anomalous Pulmonary Venous Connection

Short-term and Mid-term Outcome of Sutureless Closure for Primary Total Anomalous Pulmonary Venous Connection

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04938921
Acronym
TAPVC
Enrollment
30
Registered
2021-06-25
Start date
2019-05-30
Completion date
2024-06-01
Last updated
2021-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

TAPVC, Sutureless, Pulmonary venous stenosis

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.

Interventions

None listed

Sponsors

Children's Hospital 1
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 15 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
The percentage of pulmonary venous stenosis after reparing TAPVC with sutureless techniqueThe investigators assess the PVS at the time of 12 month after the operation.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).
Early mortality (<30 days)30 daysEarly mortality is defined when patients die within 30 days since the operation

Secondary

MeasureTime frameDescription
Late mortality (> 30 days)The investigators assess mortality at the time of 18 month after the operationLate mortality is defined when patients die beyond 30 day since the operation
The percentage of pulmonary venous stenosis after reparing TAPVC with sutureless techniqueThe 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).

Countries

Vietnam

Contacts

Primary ContactThanh QL Dinh, MSC
dql.thanh@gmail.com+84905911923

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026