Sutureless Closure for Primary Total Anomalous Pulmonary Venous Connection

NCT ID: NCT04938921

Last Updated: 2021-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-30

Study Completion Date

2024-06-01

Brief Summary

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

Detailed Description

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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

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Total Anomalous Pulmonary Venous Connection Pulmonary Venous Stenosis Sutureless Closure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital 1

OTHER

Sponsor Role lead

Responsible Party

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Thanh QL. Dinh, MD, Ms

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thoi K Ngo, MSC

Role: STUDY_DIRECTOR

Children's Hospital 1

Phuc M Vu, PhD

Role: STUDY_DIRECTOR

University of Medicine and Pharmacy in HCMC

Tuan D Nguyen, MSC

Role: STUDY_DIRECTOR

Children's Hospital 1

Linh NU Truong, PhD

Role: STUDY_DIRECTOR

University of Medicine and Pharmacy in HCMC

Locations

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Children's Hospital 1

Ho Chi Minh City, , Vietnam

Site Status RECRUITING

Countries

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Vietnam

Central Contacts

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Thanh QL Dinh, MSC

Role: CONTACT

+84905911923

Facility Contacts

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Thanh QL Dinh, MSC

Role: primary

+84905911923

Other Identifiers

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3685/QD-DHYD

Identifier Type: -

Identifier Source: org_study_id

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