View clinical trials related to Heart Defects, Congenital.
Filter by:The leading cause of birth defects, Congenital Heart Defects (CHD) affect 12 million people worldwide and 41,000 newborns/year in Europe. It's a major cause of life-long morbidity and mortality, and a crucial public health issue. More than 50% of childs born with critical CHD will develop Neurodevelopmental Disorders (NDs), requiring specific care and impairing quality of life. NDs corresponds to early and lasting disturbances in cognitive, affective and behavioral development, linked to abnormalities in brain development. They are heterogeneous, affecting language, learning, motor skills, intellectual efficiency, social cognition, attention, memory and executive functions, and are associated with psychosocial difficulties (adaptive behavior, social interactions). This hidden handicap is the main long-term sequels of CHD, even before cardiovascular sequels, in individuals who often underwent multiple heart operations in early childhood. NDs concern not only complex CHD, but also simple CHD repaired in childhood and considered cured. The origin of TND associated with CHD is largely unknown. To date, few genetic or environmental causes have been clearly identified, but recent work has suggested that a common origin may link cardiac malformation and neurodevelopmental abnormality. The CATAMARAN - Pediatrics project is designed to detect potential neurodevelopmental delays associated with CHD as early as age 3, and to identify individual susceptibility factors involved in the occurrence of NDs in CHD children.
Newborns with congenital heart disease (CHD) are at increased risk of developing postpartum and postoperative blood clots after cardiac surgery. The molecular mechanisms that are responsible for the clotting profile predisposing children to blood clots in the early stages of life are currently not well described. The goal of this proposal is to prospectively collect plasma samples from ten (10) neonates with antenatal diagnosis of severe congenital heart disease (CHD) to better understand mechanisms responsible for abnormal clotting in the perioperative period.
Congenital heart disease is one of the most common congenital defects with a high mortality and morbidity rate. Children with congenital heart disease step from pediatric care to adult care during adolescence. This situation has brought up transitional care, which is defined as "the purposeful and planned movement of adolescents and young adults with chronic physical and medical conditions from pediatric to adult-oriented health systems". Since adolescents with congenital heart disease are at high risk for complications in adulthood, it is very important to raise awareness, increase the level of readiness for adult care and gain self-management skills during the transition phase. This study was planned as a randomized controlled experimental study to evaluate the effect of the developmental transition care model applied to adolescents with congenital heart disease during the transition from pediatric care to adult care on the transition readiness level, self-management skills and care satisfaction of adolescents. Studies have shown that both adolescents with congenital heart disease and their caregivers need professional support, appropriate transition education and care before transition to adult care in order to increase adaptation to adult care, to gain self-management skills and to reduce their concerns. Studies in which adolescents are followed up after transition to adult care show that when the transition process is not successfully completed, there is excessive time between the last pediatric control and the first adult control or there are losses in further follow-up. Although there are studies in our country in which transition care is applied, this study is planned because there is no intervention study in which developmental transition care model is applied to adolescents with congenital heart disease. It is thought that this study will increase the transition readiness levels, self-management skills and care satisfaction of adolescents with congenital heart disease and guide the nurses working with them.
Feasibility and efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children aged 1 to 5 with Congenital Heart Disease
The goal of this clinical trial is to learn if the Get Ready with my Heart Program developed based on SMART theory is applicable for AYAs with CHD to enhance their Transition Readiness. The main questions it aims to answer are: 1. Is the Get Ready with my Heart Program clinically feasible？ 2. Does the Get Ready with my Heart Program improve participants' Transition Readiness? Participants will: 1. The intervention group will receive interventions according to the Get Ready with my Heart Program, while the control group will receive standard interventions. 2. Outcome measures will be collected before the implementation of the program, and at 3 months and 6 months after the implementation.
The goal of this clinical trial is to learn how well and at what doses gadopiclenol, a new intravenous (IV) contrast agent used for MRI, works to produce high-quality MRI images of the heart, in patients with a history of congenital heart disease, when compared to gadobenate dimeglumine, the IV contrast agent that is normally used at our institution for heart (cardiac) MRI. The main questions it aims to answer are: - Does using gadopiclenol result in similar or superior image quality, similar signal-to-noise ratio (SNR), and similar flow measurements with 4-dimensional (4D) flow cardiac MRI when compared to gadobenate dimeglumine? - At what dose(s) does gadopiclenol result in similar image quality (using the above metrics) for cardiac MRI when compared to gadobenate dimeglumine? Researchers will compare cardiac MRI images obtained after administration of gadopiclenol to cardiac MRI images obtained after administration of gadobenate dimeglumine (called the standard of care treatment) to see if the images are of similar or superior quality. Participants will: - Be randomized to receive either gadopiclenol at one of three different doses or gadobenate dimeglumine before their congenital heart cardiac MRI - Undergo their congenital heart cardiac MRI as they would during the course of normal clinical care.
Clinical performance of the device will be evaluated in a fully-crossed, multiple-reader multiple-case (MRMC) study. This study will be used to determine the impact of the device on reader performance in identifying suspicious radiographic findings in fetal heart ultrasound video clips recorded during 2nd trimester anatomic ultrasound examinations conducted during the second trimester of the pregnancy.
Congenital heart disease (CHD) is the most common congenital disease in children. The early detection, diagnosis and treatment of CHD in children is of great significance to improve the prognosis and reduce the mortality of children, but the current screening methods have limitations. Electrocardiogram (ECG), as an economical and rapid means of heart disease detection, has a very important value in the auxiliary diagnosis of CHD.Big data and deep learning technologies in artificial intelligence (AI) have shown great potential in the medical field. The advent of the big data era provides rich data resources for the in-depth study of CHD ECG signals in children. The development of deep learning technology, especially the breakthrough in the field of image recognition, provides a strong technical support for the intelligent analysis of electrocardiogram. The particularity of children electrocardiogram requires the development of a special algorithm model. At present, the research on the application of deep learning models to identify children's electrocardiograms is limited, and the training and verification from large data sets are lacking. Based on the Chinese Congenital Heart Disease Collaborative Research Network, this project aims to integrate data and deep learning technology to develop a set of intelligent electrocardiogram assisted diagnosis system (CHD-ECG AI system) suitable for children with CHD, so as to improve the early detection rate of CHD and improve the efficiency of congenital heart disease screening.
Delineate coronary artery anatomy and detection of coronary anomalies in children with complex cardiac anomalies by cardiac CT-angiography before total surgical correction.
The goal of this clinical trial is to learn if a computer software program (cardiac simulator) for surgical planning will lead to improvements in patient care by decreasing the incidence of unsuccessful interventions and reinterventions for pediatric patients with congenital heart disease. It is not a commercially available device to treat congenital heart disease in pediatric patients. The main aims are: To provide safe pre-operative testing of surgical approaches with a computer model cardiac simulator. To aid surgeons in envisioning different surgical approaches for each individual patient. To bolster the standard of care surgical planning discussions which will be particularly useful for patients with unique, complex congenital heart disease. Participants will: Consent to being randomized with a 50% chance of receiving standard of care "on the fly" surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of the computer software cardiac simulator. Receive results of their computer simulated findings during their surgical planning discussion if they are in the cardiac simulator group.