The Myocardial Protective Effects of a Moderate-potassium Blood Cardioplegia in Pediatric Cardiac...
Congenital Heart DiseaseThe investigators previously investigated the cardioprotective effect of an adenosine-lidocaine cardioplegia with moderate-potassium (K+, 10.0 mmol/L) in pediatric cardiac surgery, which was associated with better myocardial protective effects when compared with conventional high-potassium cardioplegia. However, this cardioplegia could not be sucked back into the cardiopulmonary bypass (CPB) circuit because of excessive hemodilution and severe systemic hypotension induced by adenosine. Therefore, the investigators supposed that a moderate-potassium (K+, 10.0 mmol/L) blood cardioplegia without adenosine could also arrest the heart and have better myocardial protective effects compared with conventional hyperkalamic cold blood cardioplegia during cardiac operations without excessive hemodilution and systemic hypotension.
Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption...
Congenital Heart DefectsDysfunctional Right Ventricular Outflow Tract ConduitsThe primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. The secondary objectives are to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.
Safety and Effectiveness of the Device "Nit-Occlud® PDA-R"
Congenital Heart DiseaseThe purpose of this study is to evaluate the safety and the effectiveness of the device "Nit-Occlud® PDA-R" in the percutaneous closure of patent ductus.
Exercise Training in Children With Congenital Heart Defect
Congenital Heart DiseaseThe purpose of this study was to investigate the effects of exercise training on exercise capacity, physical activity (PA), health-related quality of life (HRQoL), and the psychosocial factors affecting PA in sedentary congenital heart defect (CHD) children and healthy sedentary children. The degree of improvement after exercise training were compared between CHD children and healthy sedentary children.
Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation...
Heart DefectsCongenitalThis study is the extension of the CLARINET study [NCT00396877 -EFC5314] in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt. The primary objective was to assess the safety up to 18 months of age of the extended use of Clopidogrel 0.2 mg/kg/day in patients for whom the shunt was still in place at one year of age. The secondary objective was to assess the efficacy on the occurrence of shunt thrombosis requiring intervention or any death.
N-Acetylcysteine in Neonatal Congenital Heart Surgery (INACT Study)
Transposition of Great VesselsCongenital Heart DiseaseThe purpose of this study is to determine whether intravenous N-acetylcysteine (also known as Acetadote), an antioxidant medication that has been used for years to treat Tylenol overdose, helps prevent heart dysfunction in the early postoperative period following congenital heart surgery. Children undergoing major heart surgery, such as the arterial switch operation, routinely develop temporary heart dysfunction in the first 12-24 hours after surgery. This heart dysfunction may be severe and contributes to an increased risk for death or prolonged hospitalization. Current standard treatments include intravenous medications such as dopamine, epinephrine, and vasopressin that support your child's blood pressure and heart function. Unfortunately, high doses of these medications have the potential to cause severe side effects including loss of fingers and toes, liver and kidney dysfunction, and heart rhythm abnormalities. Our goal is to find a way to reduce heart dysfunction after major heart surgery in order to promote a smoother postoperative period, and reduce the risks associated with heart operations in children.
Physical Activity in Fontan Patients
Heart DefectsCongenitalThe purpose of this study is to determine which is the most effective intervention for increasing lifestyle physical activity in Fontan patients: an education (stage of change) intervention or a physical activity (mastery experience) intervention.
Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt...
Heart DefectsCongenitalContemporary management of cyanotic congenital heart disease includes three stages of surgery. Incidence of shunt thrombosis and death between the two first stages of palliation remains important. The primary objective of the study is to evaluate the efficacy of Clopidogrel 0.2 mg/kg/day for the reduction of all cause mortality and shunt related morbidity in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt (e.g. modified Blalock Taussig Shunt [BTS]). The secondary objective was to assess the safety of Clopidogrel in the study population.
Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart...
Heart DefectsCongenital2 moreThis study will evaluate the efficacy and safety of administering an angiotensin converting enzyme inhibitor (ACE-I) (enalapril) to infants with a functional single ventricle. The study will also compare the effect of ACE-I therapy to placebo on somatic growth and compare the effect of ACE-I therapy to placebo on signs and symptoms of heart failure, neurodevelopmental and functional status, ventricular geometry, function, and atrioventricular (AV) valve regurgitation. In addition, the study will determine the relationship between genetic polymorphisms linked to ventricular hypertrophy (enlarged heart) and the response to ACE-I therapy and compare the incidence of adverse events in subjects treated with ACE-I with those in subjects treated with placebo.
Study of Triostat in Infants During Heart Surgery
Heart DefectsCongenitalThis is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery.