Clinical trial NCT04234711: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Total Anomalous Pulmonary Venous Connection
Keywords: TAPVC
Surgical strategy
PVO
outcomes
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 150
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Incidence rate of postoperative pulmonary venous obstruction (PVO)
timeFrame: 2 years
measure: Mortality rate
timeFrame: 2 years
Secondary outcomes:
measure: The scores of postoperative quality of life: rating scale
timeFrame: 2 years
measure: Change in resting oxygen saturation
timeFrame: 2 years
measure: Value of tricuspid annular plane systolic excursion
timeFrame: 2 years
measure: Development of all kinds of arrhythmia
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Jian Zhuang, M.D., Ph D.
role: STUDY_DIRECTOR
References: