Sutureless Technique and Conventional Repairs for Total Anomalous Pulmonary Venous Connection

Overview

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

Full Title of Study: “Sutureless Technique and Conventional Repairs for Total Anomalous Pulmonary Venous Connection: an Observational Study by Chinese Heart Centers”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 31, 2021

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.

Interventions

  • Procedure: Surgical strategy
    • To compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection

Arms, Groups and Cohorts

  • Conventional surgical group
    • Patients with total pulmonary venous connection undergo conventional surgical repair
  • Sutureless surgical group
    • Patients with total pulmonary venous connection undergo sutureless surgical repair

Clinical Trial Outcome Measures

Primary Measures

  • Incidence rate of postoperative pulmonary venous obstruction (PVO)
    • Time Frame: 2 years
    • in anastomosis or arborizations of pulmonary veins
  • Mortality rate
    • Time Frame: 2 years
    • all causes and surgical repair related

Secondary Measures

  • The scores of postoperative quality of life: rating scale
    • Time Frame: 2 years
    • Fill the rating scale through telephone or other communication
  • Change in resting oxygen saturation
    • Time Frame: 2 years
    • Answer question through telephone or other communication
  • Value of tricuspid annular plane systolic excursion
    • Time Frame: 2 years
    • Measured by echocardiology from follow-up
  • Development of all kinds of arrhythmia
    • Time Frame: 2 years
    • Measured by electrocardiography

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: N/A

Maximum Age: 1 Year

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Guangdong Provincial People’s Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jian Zhuang, M.D., Ph D., Study Director, Guangdong Provincial People’s Hospital
  • Overall Contact(s)
    • Rong Liufu, M.D., 020-83827812, liufurong103@163.com

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