UnknownNot Applicable

Sutureless Closure for Primary Total Anomalous Pulmonary Venous Connection

Vietnam30 participantsStarted 2019-05-30

Plain-language summary

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

Who can participate

Age range

15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Early mortality (<30 days)

Timeframe: 30 days

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

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

Trial details

NCT IDNCT04938921

SponsorChildren's Hospital 1

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-06-01

Contact for this trial

Thanh QL Dinh, MSC

+84905911923 dql.thanh@gmail.com

View on ClinicalTrials.gov More Total Anomalous Pulmonary Venous Connection trials

Who can participate

Age range

15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

Early mortality (<30 days)

Timeframe: 30 days

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

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