View clinical trials related to Heart Defects, Congenital.
Filter by:Rationale: During cardiac surgery, neonates are at high risk of cerebral damage: 36-78% will have new cerebral lesions after surgery. Adequate cerebral perfusion (CBF) is mandatory to prevent postoperative brain damage and neurobehavioral outcomes. For CBF, the systemic blood pressure should be managed above the brain's critical closing pressure (CrCP), and preferably above the lower limit of autoregulation (LLA), if intact. Objective: The investigators aim to study the patient specific threshold for arterial blood pressure to maintain adequate cerebral perfusion (CBFV) in the perioperative setting and the association between perioperative abnormalities with postoperative brain damage and neurobehavioral outcomes. Study design: In a prospective observational cohort study bilateral cerebral blood flow velocity (CBFV) measurements are performed with transcranial doppler (TCD), together with invasive arterial blood pressure (iABP) measurements in the perioperative period. Study population: Neonates (semi-) electively scheduled for major cardiac- and non cardiac surgery. Main study parameters/endpoints: Main study endpoint is the Critical Closing Pressure (CrCP) within and between subjects. Furthermore, we evaluate the association with new white matter injury (WMI) on the postoperative MRI. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Anticipated risks caused by TCD monitoring in neonates are considered negligible when monitoring is executed according to the BMUS guidelines and ALARA principle. Each time energy is converted from one form to another, part of it is inevitably converted to heat. Theoretically, if at all, the maximum temperature rise will happen at the skin- temporal bone side, where the monitoring probes are placed. A maximal thermal index (TI) of 0.7 is allowed, this corresponds with 0.7 o C temperature rise. Patients might not benefit from participation in this study as the TCD measurements are only visible and available to the TCD operator, and we do not yet know how the results could possibly influence the procedure. However, in the unlikely situation where cerebral perfusion is severely compromised for a longer period of time or in case of occurrence of large air emboli, improper cannulation or cross clamping the cardiac team will be notified. Therefore, a neonate might benefit from participation.
This is a Phase III randomized controlled trial of a passive ROM exercise program that will be performed in infants with HLHS and other single right ventricle anomalies following the Norwood procedure at PHN and Auxiliary Centers.
This feasibility study will assess whether a 6-month, home-based, parent-led physical activity program, completed after surgical or catheterization treatment, enables young children with congenital heart defects (CHD) to achieve the recommended 180 minutes of daily physical activity. This study includes comprehensive measures of motor skill and physical activity, intervening at a very young age, and targeting the high risk status for sedentary lifestyles of children with CHD. This study will provide essential data on patient recruitment, data collection procedures, the proposed physical activity intervention and resources required to enable the design of a randomized controlled trial (RCT) to evaluate play-based, parent-delivered interventions optimized to support age-appropriate physical activity and motor skills among young children with CHD.
The incidence of moderate to severe congenital heart disease (CHD) in the United States is estimated to be 6 per 1000 live-born full term infants. Recent advances in pediatric cardiology, surgery and critical care have significantly improved the survival rates of patients with CHD leading to an increase in prevalence in both children and adults. Children with CHD significant enough to require cardiac surgery frequently also undergo non-cardiac surgical procedures. Analysis of the Pediatric Health Information System database between 2004 and 2012 demonstrated that 41% of children who had undergone surgery to correct CHD in the first year of life also underwent at least one non-cardiac surgery by age 5. With this increased demand for non-cardiac procedures, anesthesiologists, pediatricians and other healthcare providers will encounter patients with repaired or unrepaired CHD and other cardiac diseases in their practice. However, the information provided by national databases lack granularity and the information from single institutional data is limited. This project aims to address this knowledge gap in quantifying the risk for cardiac patients coming for noncardiac procedures and identify the health care resource utilization and system to best care for this patient population. To conduct this study, we will create a multi-institutional collaboration between large and small centers to create a unique dataset spanning all the different variables that need to be considered in risk prediction for these patients including patient variables, hospital setting, and providers. The aggregate multiinstitutional data set may be used for benchmarking for national quality improvement efforts.
The objective of this study is to determine the effectiveness of a real time continuous risk analytics algorithm in the successful de-escalation of vasoactive and inotropic support in pediatric patients following cardiac surgery.
Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect
Positive intra-thoracic pressures induced by mechanical ventilation can negatively impact right heart hemodynamics by restricting systemic venous return and increasing right ventricular afterload. These consequences may be detrimental in patients with a restrictive right ventricular physiology and in patients with single ventricle physiology. NAVA (Neurally Adjusted Ventilatory Assist) ventilation decreases intra thoracic pressures compared to conventional ventilation modes. Brain perfusion is both a hemodynamic indicator and a prognostic factor in cardiac postoperative care. Diffuse Correlation Spectroscopy (DCS) coupled with Near Infrared Spectroscopy (NIRS) is a new technology that allows monitoring, in addition to brain tissue oxygenation, changes in brain blood flow. This physiological study aims to evaluate the impact of NAVA mode ventilation on cerebral and systemic hemodynamics in post-operative cardiac surgery patients with preload dependant right ventricle or with passive venous return to the lungs . This prospective cross-over study will include 30 patients. Once stabilized in intensive care, patients will undergo 2 periods of ventilation in NAVA mode and conventional mode separated by a 30-minute washout period, in a random order. For each period the following information will be collected: changes in cerebral blood flow and cerebral oxygenation, hemodynamic parameters including cardiac output and oxygen transport and ventilatory parameters.
Congenital heart disease (CHD), the most common birth defect, is present in nearly 1% of the population. CHD patients are associated with intense resource utilization and premature death in adulthood. The risk of premature death is linked with reduced exercise capacity, a finding consistently noted in youth with CHD. Reduced exercise capacity in this population has also been associated with reduce physical activity and health-related quality of life. Cardiac rehabilitation (CR) in adults with acquired heart disease is an established secondary prevention strategy that improves exercise capacity. The investigators propose a prospective clinical trial of a home-based high intensity interval training (HIIT) program using a novel telemedicine-equipped video game-linked cycle ergometer (MedBIKE™) for 10 to 18 year olds with repaired moderate-complex CHD. The pilot study with the MedBIKE has shown promising results. The investigators now seek to study the efficacy of this program in a broader CHD population.
Neurodevelopmental disability is the most significant complication for survivors of infant surgery for congenital heart disease. In this study we sought to determine if intraoperative continuous infusion of dexmedetomidine are associated with neurodevelopmental outcomes at 12 months.
A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.