Clinical Trials Logo

Clinical Trial Summary

Transposition of the great arteries (TGA) is a complex cyanotic congenital heart disease and patients suffer from a high mortality rate within one year of age without appropriate management. The therapeutic effect of arterial switch operation (ASO) is satisfactory with low surgery mortality of 2-5%, and thus, has become the treatment of choice for surgical correction of d-TGA. Outcomes of ASO in TGA in china are rare. This is a retrospective study reporting the outcomes of ASO in TGA.


Clinical Trial Description

Transposition of the Great Arteries (TGA) is a relatively rare congenital heart disease and surgical treatment in China was developed in recent 20 years. The outcomes of arterial switch operation (ASO) in TGA in China have not been reported before. This study was designed to offer the experience of surgical treatment of TGA in two major pediatric heart centers affiliated in national children's medical center in China. In this retrospective study, a total of 1281 patients diagnosed with TGA received ASO treatment in Fudan Children's Hospital and Shanghai Children's Medical Center were recruited. Medical records and follow-up data of patients were complete. Patient characteristics and clinical data were obtained through review of the medical records, preoperative echocardiography and cardiac catheterization data, operative notes, and follow up reports. Description of the anatomy was confirmed on the preoperative echocardiogram, with clarification from the operative note as needed. Anatomy of the coronary arteries were collected based on the surgical notes. Perioperative data included aorta cross clamping time, cardiopulmonary bypass time and the application of Lecompete maneuver. Early postoperative complications are defined as delayed sternal closure, active bleeding after surgery, pulmonary artery stenosis, coronary artery re-transplantation, residual ventricular septal defect with significant shunt, atrioventricular block, extracorporeal membrane oxygenation support, cardiac arrest, necrotizing enterocolitis and diaphragmatic eventration. Hospital death was defined as death occurred before discharge. Follow-up results included echocardiography, cardiac CTA, cardiac catheterization, and angiography. Echocardiographic assessment included color, continuous wave, and pulse wave Doppler date for all valves. Peak pressure gradient of 20mmHg was considered to be stenotic for neoaortic and pulmonary valve. Redo-procedure was defined as any kind of cardiovascular intervention after the ASO procedure including surgery or catheter-based procedure. The indication for reintervention of pulmonary or suprapulmonary stenosis was peak pressure gradient over 40mmHg. Pressure gradient across the LVOT or aortic valve over 50 mmHg was the indication for reintervention. Late death was defined as death occurred during follow up. Relationships between preoperative and perioperative factors and hospital mortality were evaluated. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05089773
Study type Observational
Source Children's Hospital of Fudan University
Contact
Status Completed
Phase
Start date December 1, 2019
Completion date April 30, 2020

See also
  Status Clinical Trial Phase
Completed NCT04735055 - Artificial Intelligence Prediction for the Severity of Acute Pancreatitis
Recruiting NCT06006975 - Early Warning of Delayed Cerebral Ischemia
Not yet recruiting NCT05983549 - Neutral Versus Liberal fLuId In Traumatic Brain Injury: a Randomised Controlled Trial N/A
Recruiting NCT05788861 - Invasive Group A Streptococcal Infection
Completed NCT03104946 - To Research the Relation Between Neonatal Morbidities and Poor Outcome in Preterm Infants N/A
Not yet recruiting NCT04584463 - Factors Associated With CPC 1-2 in 110 Patients Admitted in French ICU for a Myocardial Infarction Complicated by an OHCA.
Completed NCT04235920 - Cognitive Impairment and Outcome of Acute Ischemic Stroke.
Not yet recruiting NCT04582188 - The Early Coagulopathy for the Prognosis in Sepsis
Completed NCT04260334 - Preoperative Care In Ovarian Cancer Patients N/A
Recruiting NCT04121429 - Stopping Cardiovascular Treatments and Mortality in a MICU
Completed NCT05338593 - Therapy and Outcome of Prolonged Veno-venous ECMO Therapy of Critically Ill ARDS Patients.
Not yet recruiting NCT04339322 - Characteristics and Outcome of Coronavirus Disease 2019 (COVID-19) in Egypt
Completed NCT03619759 - The Effect of Sugammadex on the Outcome After Colorectal Cancer Surgery
Not yet recruiting NCT06146270 - Russian Registry of Surgical OutcomeS
Completed NCT04542954 - Optimized Management of Covid-19 Positive Kidney Transplant Recipients: Single Center Experience From the Middle East
Withdrawn NCT03228043 - Apatinib for Resectable Colorectal Cancer N/A
Completed NCT04292964 - Prognostic Factors of Patients With COVID-19
Completed NCT03470571 - CMR Features in Patients With Suspected Myocarditis
Active, not recruiting NCT04293653 - Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy N/A
Not yet recruiting NCT04683458 - Analysis of Linked Health Insurance Claims and Clinical Registries to Determine Device Surveillance With Paclitaxel-coated Medical Devices