Sutureless Closure for Primary Total Anomalous Pulmonary Venous Connection (TAPVC)

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.

Study Overview

• Status: Recruiting
• Conditions: Total Anomalous Pulmonary Venous Connection; Pulmonary Venous Stenosis; 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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Thanh QL Dinh, MSC; Phone Number: +84905911923; Email: dql.thanh@gmail.com

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam, 70000
    • Recruiting
    • Children's Hospital 1
    • Contact: Thanh QL Dinh, MSC; Phone Number: +84905911923; Email: dql.thanh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late mortality (> 30 days)	Late mortality is defined when patients die beyond 30 day since the operation	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).	The investigators assess the PVS at the time of 6 month after the operation.

Collaborators and Investigators

• Sponsor: Children's Hospital 1
• Investigators: Study Director: 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 record dates

Study Major Dates

• Study Start (Actual): May 30, 2019
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): June 25, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Sutureless; TAPVC; Pulmonary venous stenosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Respiratory System Abnormalities; Scimitar Syndrome
• Other Study ID Numbers: 3685/QD-DHYD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No