Total Anomalous Pulmonary Venous ConnectionTAPVCNCT04938921
Sutureless Closure for Primary Total Anomalous Pulmonary Venous Connection
An observational study of Total Anomalous Pulmonary Venous Connection and Pulmonary Venous Stenosis, run by Children's Hospital 1 at 1 site in Vietnam.
Trial summary
The purpose of this study is to assess the percentage of pulmonary venous stenosis after TAPVC repair with sutureless closure. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Total Anomalous Pulmonary Venous Connection, Pulmonary Venous Stenosis, Sutureless Closure
- How many people
- 30 participants
- Where
- 1 siteVietnam
- Study dates
- 30 May 2019to 1 Jun 2024
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- Child
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
Who may be able to join
- All patients with TAPVC operated with sutureless closure and be agreed to join this study by parents from 01/2019 to 06/2024.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Children's Hospital 1
Ho Chi Minh City, 70000
Thanh QL Dinh, MSC, +84905911923, dql.thanh@gmail.com
About this study
Official title: Short-term and Mid-term Outcome of Sutureless Closure for Primary Total Anomalous Pulmonary Venous Connection
The purpose of this study is to assess the percentage of pulmonary venous stenosis after TAPVC repair with sutureless closure.
Read the 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.
- Conditions
- Total Anomalous Pulmonary Venous Connection, Pulmonary Venous Stenosis, Sutureless Closure
- Keywords
- TAPVC, Sutureless, Pulmonary venous stenosis
- Medical subject headings
- Scimitar Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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).
Measured: The investigators assess the PVS at the time of 18 month after the operation.
Secondary outcomes (2)
Late mortality (> 30 days)
Late mortality is defined when patients die beyond 30 day since the operation
Measured: 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 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).
Measured: The investigators assess the PVS at the time of 6 month after the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start30 May 2019
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Anomalous Pulmonary Venous ConnectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Children's Hospital 1
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thanh QL. Dinh, MD, Ms, Children's Hospital 1
- Investigators
- Thoi K Ngo, MSC, Study director, Children's Hospital 1Phuc M Vu, PhD, Study director, University of Medicine and Pharmacy in HCMCTuan D Nguyen, MSC, Study director, Children's Hospital 1Linh NU Truong, PhD, Study director, University of Medicine and Pharmacy in HCMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938921
- Sponsor's protocol ID
- 3685/QD-DHYD
- Acronym
- TAPVC
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2021
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term and Mid-term Outcome of Sutureless Closure for Primary Total Anomalous Pulmonary Venous Connection
- ClinicalTrials.gov ID
- NCT04938921
- Acronym / sponsor ID
- TAPVC / 3685/QD-DHYD
- Conditions
- Total Anomalous Pulmonary Venous Connection, Pulmonary Venous Stenosis, Sutureless Closure
- Keywords
- TAPVC, Sutureless, Pulmonary venous stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Children's Hospital 1University, hospital or other
- Study start
- 30 May 2019 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 18 Months
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- All patients with TAPVC operated with sutureless closure and be agreed to join this study by parents from 01/2019 to 06/2024.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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)
Time frame: 30 days
Early mortality is defined when patients die within 30 days since the operation
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.
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).
2 secondary outcomes
Late mortality (> 30 days)
Time frame: 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
Time frame: The investigators assess the PVS at the time of 6 month after the operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thoi K Ngo, MSC study director
Children's Hospital 1
Phuc M Vu, PhD study director
University of Medicine and Pharmacy in HCMC
Tuan D Nguyen, MSC study director
Children's Hospital 1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Anomalous Pulmonary Venous Connection and Pulmonary Venous Stenosis, run by Children's Hospital 1 at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thanh QL Dinh, MSC (+84905911923, dql.thanh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.