Loading clinical trials...
Loading clinical trials...
Showing 1-10 of 10 trials
NCT07114718
Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the Lifeline Ductus Arteriosus Stent System. The study device is a stent that is designed to maintain patency of the Ductus Arteriosus for children who need blood flow through that part of the heart.
NCT07204509
Congenital heart disease (CHD) is one of the most common birth defects and an important cause of infant morbidity and mortality. Many children with CHD also have underlying genetic abnormalities, particularly chromosomal abnormalities, which may affect their prognosis, management, and counseling. This study aims to determine the incidence and pattern of chromosomal abnormalities among children with CHD attending Assiut University Children's Hospital and Elmabara Insurance Hospital. Children with a confirmed diagnosis of CHD will undergo a detailed clinical assessment, including dysmorphic evaluation, followed by chromosomal analysis (karyotyping). The study will help identify the frequency and type of chromosomal abnormalities associated with CHD and their correlation with specific cardiac defects and phenotypic features. Understanding these genetic associations may improve diagnosis, early intervention, and family counseling, and provide useful information for risk stratification and prevention strategies in the Egyptian population.
NCT07055347
This single-arm feasibility study will pilot a home-based cardiac rehabilitation program for preschool children (aged 3 to 7 years) who have undergone corrective surgery for congenital heart disease. Following the development of the program through expert consensus, this phase will implement the preliminary version of the program in a selected sample of caregiver-child pairs over a 12-week period. The study will assess feasibility by evaluating caregiver adherence to the intervention, acceptability of the program components, and completeness of rehabilitation task records. Descriptive data on safety, participation rate, and delivery logistics will also be collected. Findings will inform refinement of the program prior to future effectiveness testing.
NCT06912412
This study is to develop a 12-week community-based remote cardiac rehabilitation program for pediatric patients with complex congenital heart disease and to assess its validity and safety. For these children, a multidisciplinary approach including pediatric rehabilitation medicine, pediatric thoracic surgery, pediatrics, pediatric psychiatry, sports science, and nutrition is essential, but such comprehensive services are rarely available in Korea. As a result, pediatric cardiac rehabilitation at the community level is nearly nonexistent. Recent long-term retrospective cohort studies suggest that maintaining regular physical activity and aerobic capacity from early childhood significantly reduces future cardiovascular complications, emphasizing the importance of early pediatric cardiac rehabilitation. However, participation in existing programs is low due to limited accessibility. The investigators hypothesize that a community-based remote cardiac rehabilitation program for these patients is both valid and safe. Participants will be children aged 8-18 years diagnosed with complex congenital heart disease , at least 3 months post-surgery, and stable cardiovascular status. Interventions include supervised and self-directed cardiac rehabilitation exercises. Monitoring (heart rate, SpO2, ECG) will be performed in real-time, with non-real-time data collection of physical activity using smartwatches. The intervention lasts 12 weeks with a 12-week follow-up. Validity measures include baseline evaluation, adherence, dropout rate, participant and parent satisfaction, and changes in cardiopulmonary exercise capacity, physical activity, body composition, fitness (6-minute walk, strength, flexibility, respiratory muscle strength), and questionnaires (physical activity, quality of life, exercise satisfaction, depression, psychological state). Safety will be assessed by monitoring adverse events, vital signs, fatigue (Borg scale), and pain before and after exercise.
NCT06845371
Extension of the MELODY Registry, to assess longterm follow-up clinical results of Melody valve implantation after its commercialization in Europe / OUS
NCT06777615
The objective of the study is to create an electronic archive in which to census all newly diagnosed or already diagnosed cases of infective endocarditis and congenital heart disease after 01 January 2022 at the IRCCS AOU Bologna Pediatric and Developmental Age Cardiology Center so that be able to describe the clinical and echocardiographic features in patients with congenital heart disease and infective endocarditis in this population in order to be able to define new diagnostic/epidemiological hypotheses and the identification of predictive factors of adverse outcome (death, re-intervention, re-hospitalization) in patients with congenital heart disease and EI.
NCT06686550
The investigators are going to conduct a prospective observational cohort study in pediatric patients aged 28 days to 14 years old scheduled for elective cardiac surgery with cardiopulmonary bypass. The primary purpose of this study is to explore the effect of preoperative sleep disturbance on the incidence of postoperative delirium. Sleep status will be assessed using the Brief Infant Sleep Questionnaire(BISQ) and Children's Sleep Habits Questionnaire (CSHQ), and postoperative delirium status will be evaluated by Cornell assessment of pediatric delirium(CAPD). During the peri-operative period, children will wear actigraphs to record their sleep parameters.
NCT06659302
Children with congenital heart disease are at much higher risk for behavioral and emotional difficulties in early childhood and beyond 1. However, intervention programs aimed at this population are limited and few have explored the efficacy of behavioral parent training on child behavior and parent stress in children with CHD. Few evidence-based behavior intervention programs are available in the community for families of children with CHD and behavioral struggles and many families struggle to stick with long-term treatment given the multiple appointments and responsibilities that are often already associated in parenting children with chronic health conditions. As such, more targeted, shorter and more accessible interventions are very needed. Established internet-based treatments such as I-InTERACT-North, are particularly well-suited for adaptation to stepped-care delivery due to prior implementation success, readily adaptable intensity of online content and therapist contact. This study will evaluate whether I-InTERACT North is a feasible intervention to implement in a step-care model and whether it is acceptable to families and impacts behavior and family functioning.
NCT02644824
Surgery with cardiopulmonary bypass (CPB) for congenital heart disease (CHD) causes low cardiac index (CI). With the increasing success of surgery for CHD, mortality has decreased and emphasis has shifted to post-operative morbidity and recovery. Children with CHD undergoing surgery with CPB can experience well-characterized post-operative cardiac dysfunction. When severe, patients can develop clinically important low cardiac output syndrome (LCOS) and hemodynamic instability. Management of LCOS and hemodynamic compromise is primarily accomplished via intravenous durgs like milrinone, dopamine or dobutamine, which affect the strength of the heart's muscular contractions. These are used to maintain adequate blood pressure (BP) and CI. However, inotropic agents are potentially detrimental to myocardial function and may increase risk for post-operative arrhythmia and impair post-operative recovery by increasing oxygen demand and myocardial oxygen consumption (VO2). In combination with the increased VO2 associated with CPB-induced systemic inflammatory response patients can develop a critical mismatch between oxygen supply and demand, essentially the definition of LCOS. Therefore, therapies that improve CI and hemodynamic stability without increased VO2 are beneficial. This study will test whether BiVp, a specialized yet simple pacing technique, can improve post-operative CI and recovery in infants with electro-mechanical dyssynchrony (EMD) after CHD surgery. This study hypothesizes that Continuous BiVp increases the mean change in CI from baseline to 48 hours in infants with EMD following CHD surgery compared to standard care alone.
NCT02303535
The National Institute of Cardiovascular Outcomes Research (NICOR) collects data and produces analysis to enable hospitals and healthcare improvement bodies to monitor and improve the quality of care and outcomes of cardiovascular patients. The Congenital Heart Disease audit collects data on all cardiac surgery and therapeutic cardiac catheterisations procedures used to treat patients with congenital and acquired heart disease. For acquired heart disease, the audit covers all arrhythmias \& cardiomyopathies in patients less than 16 years old only. For congenital heart disease, the audit collects data on both children and adult patients. The audit covers all specialist centers in the UK and Republic of Ireland. The project aims to improve the quality of care for children and adults with congenital heart disease by providing national comparative analysis of procedure specific activity and outcomes of cardiac surgery and therapeutic cardiac catheterisation procedures. The audit also provides quality indicators for the antenatal detection of major congenital heart disease. The current dataset is available from here: http://www.ucl.ac.uk/nicor/audits/congenital/datasets