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.
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
Incidence rate of postoperative pulmonary venous obstruction (PVO)
The scores of postoperative quality of life: rating scale
Total Anomalous Pulmonary Venous Connection
Study Arms / Comparison Groups
Conventional surgical group
Description: Patients with total pulmonary venous connection undergo conventional surgical repair
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
February 20, 2020
February 1, 2022
Primary Completion Date
August 31, 2021
1. Infants and neonates who are diagnosed with TAPVC
2. Infants and neonates who undergo initial surgical repair for TAPVC.
1. Concommitant diagnoses including functional single ventricular, double outlet right
ventricle, tricuspid atresia, pulmonary atresia, or transposition of the great
2. Older than 1-year-old.