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Sutureless Technique and Conventional Repairs for Total Anomalous Pulmonary Venous Connection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04234711
Recruitment Status : Recruiting
First Posted : January 21, 2020
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Guangdong Provincial People's Hospital

Brief Summary:
The purpose of this study is to evaluate the efficacy of conventional repair and sutureless surgical repair of total anomalous pulmonary venous connection.

Condition or disease Intervention/treatment
Total Anomalous Pulmonary Venous Connection Procedure: Surgical strategy

Detailed Description:

An observational, non-randomized multi-center study is proposed to compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection. Subjects will be enrolled at Guangdong Provincial People's Hospital (GPPH) and three to five participating hospitals. All clinical interventions will follow the participating hospital's standard of care. Informed consent will be obtained from all study participants before study enrollment. After undergoing their surgical repairs, study participants will be followed up at 1, 3, 6 and 12 months after initial surgery and annually thereafter. All preoperative and postoperative medical records data will be submitted to a centralized database at GPPH through a secure online research platform.

Baseline and post-operative (6 months) assessments will include a history and physical examination, a quality of life survey, physical examinations, liver and kidney function assessments, serum brain natriuretic peptide (BNP), echocardiography and electrocardiography. Besides, a small amount of common pulmonary vein tissue may be required for hematein and eosin staining.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sutureless Technique and Conventional Repairs for Total Anomalous Pulmonary Venous Connection: an Observational Study by Chinese Heart Centers
Estimated Study Start Date : February 20, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Conventional surgical group
Patients with total pulmonary venous connection undergo conventional surgical repair
Procedure: Surgical strategy
To compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection

Sutureless surgical group
Patients with total pulmonary venous connection undergo sutureless surgical repair
Procedure: Surgical strategy
To compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection




Primary Outcome Measures :
  1. Incidence rate of postoperative pulmonary venous obstruction (PVO) [ Time Frame: 2 years ]
    in anastomosis or arborizations of pulmonary veins

  2. Mortality rate [ Time Frame: 2 years ]
    all causes and surgical repair related


Secondary Outcome Measures :
  1. The scores of postoperative quality of life: rating scale [ Time Frame: 2 years ]
    Fill the rating scale through telephone or other communication

  2. Change in resting oxygen saturation [ Time Frame: 2 years ]
    Answer question through telephone or other communication

  3. Value of tricuspid annular plane systolic excursion [ Time Frame: 2 years ]
    Measured by echocardiology from follow-up

  4. Development of all kinds of arrhythmia [ Time Frame: 2 years ]
    Measured by electrocardiography


Biospecimen Retention:   Samples Without DNA
Common pulmonary vein tissue for histopathology of abnormal vein


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neonates and infants undergoing initial operation for total anomalous pulmonary venous connection in the participating hospitals of this study.
Criteria

Inclusion Criteria:

  1. Infants and neonates who are diagnosed with TAPVC
  2. Infants and neonates who undergo initial surgical repair for TAPVC.

Exclusion Criteria:

  1. Concommitant diagnoses including functional single ventricular, double outlet right ventricle, tricuspid atresia, pulmonary atresia, or transposition of the great arteries.
  2. Older than 1-year-old.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04234711


Contacts
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Contact: Rong Liufu, M.D. 020-83827812 liufurong103@163.com

Locations
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China, Guangdong
Guangdong Provincial People's Hospital Recruiting
Guangzhou, Guangdong, China, 520000
Contact: Xiaobing Liu, M.D., Ph. D    15989201782    liuxb21@aliyun.com   
Sponsors and Collaborators
Guangdong Provincial People's Hospital
Investigators
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Study Director: Jian Zhuang, M.D., Ph D. Guangdong Provincial People's Hospital
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Responsible Party: Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT04234711    
Other Study ID Numbers: 20190505
First Posted: January 21, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guangdong Provincial People's Hospital:
TAPVC
Surgical strategy
PVO
outcomes
Additional relevant MeSH terms:
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Scimitar Syndrome
Lung Diseases
Respiratory Tract Diseases
Respiratory System Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Congenital Abnormalities