Sutureless Technique and Conventional Repairs for Total Anomalous Pulmonary Venous Connection

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

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

Study Overview

• Status: Unknown
• Conditions: Total Anomalous Pulmonary Venous Connection
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 520000
      • Recruiting
      • Guangdong Provincial People's Hospital
      • Contact: Xiaobing Liu, M.D., Ph. D; Phone Number: 15989201782; Email: liuxb21@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Investigators: Study Director: Jian Zhuang, M.D., Ph D., Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 20, 2020
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: January 12, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 21, 2020

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: outcomes; TAPVC; Surgical strategy; PVO
• 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: 20190505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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