Sutureless Technique and Conventional Repairs for Total Anomalous Pulmonary Venous Connection

Brief Title

Sutureless Technique and Conventional Repairs for Total Anomalous Pulmonary Venous Connection

Official Title

Sutureless Technique and Conventional Repairs for Total Anomalous Pulmonary Venous Connection: an Observational Study by Chinese Heart Centers

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.
    

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.
    


Study Type

Observational


Primary Outcome

Incidence rate of postoperative pulmonary venous obstruction (PVO)

Secondary Outcome

 The scores of postoperative quality of life: rating scale

Condition

Total Anomalous Pulmonary Venous Connection

Intervention

Surgical strategy

Study Arms / Comparison Groups

 Conventional surgical group
Description:  Patients with total pulmonary venous connection undergo conventional surgical repair

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

150

Start Date

February 20, 2020

Completion Date

February 1, 2022

Primary Completion Date

August 31, 2021

Eligibility 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.
      

Gender

All

Ages

N/A - 1 Year

Accepts Healthy Volunteers

No

Contacts

Jian Zhuang, M.D., Ph D., 020-83827812, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04234711

Organization ID

20190505


Responsible Party

Sponsor

Study Sponsor

Guangdong Provincial People's Hospital


Study Sponsor

Jian Zhuang, M.D., Ph D., Study Director, Guangdong Provincial People's Hospital


Verification Date

January 2020