View clinical trials related to Congenital Heart Disease.
Filter by:Congenital heart disease (CHD) defined as anatomic malformation of the heart and great vessels which occurs during intrauterine development irrespective of the age of presentation(1) It is classified into acyanotic and cyanotic depending upon whether the patients clinically exhibit cyanosis(2) . It is the most common human developmental anomaly with a reported prevalence of between 4 to 10 per 1000 live birth (3-6). The variety and severity of clinical presentation depend on the cardiac structures involved and their functional impact (7). Previous studies have found that, although birth weight for gestational age is usually normal in patients with congenital heart disease, young children often present with impaired growth parameters (8,9) The underlying causes of this failure to thrive may be multifactorial including innate growth potential, severity of cardiac underlying disease, increased energy requirements ,decreased nutritional intake, malabsorption and poor utilization of absorbed nutrients .these factor are particularly common and sever in low and middle income countries (11) Several studies suggest that the failure to thrive is associated with poorer cognitive development, learning disabilities, and long term behavioral problems more recently Corbett et al (12) detected a significant association between the severity of growth deficiency and IQ ,whereas Raynor and Rudolf (13) found that 55% of the infants who were failing to thrive exhibited developmental delay .In addition , A study by Reif et al (14) reported that children with a history of failure to thrive were found to have more learning difficulties and evidenced developmental delay at follow up 5 years after the initial presentation(15). Achieving survival is not the only target of clinicians for these patients, appropriate growth, development and improved quality of life are also very important. The management of children with congenital heart disease require multidisciplinary approach,in which the nutritional aspect plays an important role ,an adequate caloric intake, in fact this improve the out come of these patients.(7) This study will asses the nutritional status for patients with congenital heart disease Who are admitted at assiut university hospital children and adopting a protocol for nutritional support for them.
To evaluate if there is any clinical difference in patients 3.5-12kg who undergo cardiac surgery with cardiopulmonary bypass that do and do not receive blood products as part of their procedure. The main hypothesis of the study is that the patients undergoing bloodless cardiac surgery will have decreased morbidity and mortality when compared to the cohort that did receive blood as well as a shorter ICU and hospital length of stay.
This study has the goal to determine the best method of respiratory support following extubation after cardiac surgery (CS). After cardiac surgery for Congenital Heart Disease (CHD), patients remain intubated until the cardiac team determines it is safe for the patient to undergo a trial of extubation. Two common methods of respiratory support following extubation are High Flow Nasal Cannula (HFNC) and Non Invasive Positive Pressure Ventilation (NIPPV). There is currently a gap in data comparing High Flow Nasal Cannula and Non-Invasive Positive Pressure Ventilation in infants (age 0-1) in regard to extubation failure and overall outcomes. This study will monitor the health outcomes of 200 infants (0 - 1 year) with CHD following cardiac surgery in the Cardiac Intensive Care Unit (CICU) at Children's Healthcare of Atlanta (CHOA). This will be done by assigning the respiratory support method each child will receive following extubation after cardiac surgery. Health outcomes will be monitored until discharge or until the second instance of extubation failure. Both study arms are standard-of-care respiratory support methods in the CHOA CICU. The investigators aim to determine which of these two methods has fewer risk factors when used with infants.
Sinus venosus defect (SVD) accounts for 10% of atrial septal defects and is characterized by an anomalous pulmonary venous return in the superior vena cava associated with a high situated atrial septal defect. Since 2013, transcatheter correction of this congenital heart disease has emerged as a new treatment option. The procedure involves placement of a covered stent in the superior vena cava that tunnels the anomalous pulmonary venous return to the left atrium. Preliminary results are limited but promising. The devices to be used depend on anatomic considerations. XXL stents than 70mm are often required. Today, the availability of CE marked stents is limited. There have been recent reports of successful corrections with the specifically developed Optimus XXL 100mm covered stent (ANDRATEC) with compassionate approval from the Agence Nationale de Sûreté du Médicament in France. Setting up a feasibility study to investigate the use of medical devices in this indication was required. The objective of this project is to study the feasibility, efficacy and safety of the Optimus stent in this newly developed transcatheter procedure, in comparison with the gold-standard surgical method. A French national multicenter comparative cohort study including all eligible patients referred for transcatheter correction of SVD was designed. The feasibility of the transcatheter procedures will be investigated beforehand by virtual digital simulation and simulation on a 3D printed model. The procedures will then be performed in centers of the M3C network for complex congenital heart diseases (CARDIOGEN). The primary endpoint will be a composite of efficacy, defined as complete occlusion of the shunt, and safety, defined as the absence of major events at 6 months. The secondary endpoints will be anatomical, functional and psychosocial (quality of life). It is expected that transcatheter treatment gives comparable results to surgery on the primary endpoint. This could justify the further development of this procedure as an alternative to surgery and facilitate the validation of dedicated equipment.
Congenital heart disease (CHD) is associated with daily stressors and functional impairments that can cause negative emotions. Emotion regulation abilities may determine whether people with CHD develop psychopathology or adapt to the illness-related regulatory demands. This three-arm randomized clinical trial evaluates the efficacy of emotion regulation interventions in individuals with CHD. Patients with CHD over 18 years will be randomly assigned to a CHD-specific web-based emotion regulation intervention, a general web-based emotion regulation intervention, or a waitlist control group with delayed intervention access (8 weeks). The interventions are based on cognitive behavioral therapy, including everyday emotion regulation exercises and psychoeducation via video and audio files. Four and eight weeks after baseline, emotion regulation, well-being, depression, anxiety, perceived stress, life satisfaction, and illness identity will be assessed. Both interventions are expected to improve emotion regulation abilities, well-being, depressive symptoms, anxiety, perceived stress, life satisfaction, and illness identity four and eight weeks after baseline compared to the waitlist control group. The disease-specific intervention is hypothesized to be superior as it targets everyday emotional problems in CHD patients.
The overall goal of this program is to create a remote, mobile application enabled exercise program for patients with Congenital Heart Disease (CHD). Pilot trials will consist of a remote exercise program with app-embedded exercise modules designed to promote and encourage safe and healthy exercise habits across a range of CHD anatomies. This app-enabled program will allow for real time data collection integrating wearable devices, as well as compliance and safety monitoring to enhance research capabilities. The app-enabled program will be versatile and may be applied in the future to patients with non-cardiac conditions.
The goal of this clinical trial is to compare pain management in neonates and infants under 3 years of age undergoing cardiac surgery with use of cardiopulmonary bypass. Patients will be randomized to either continuous morphine IV (standard) of intermittent paracetamol IV (intervention). The investigators' hypothesis is that intermittent IV paracetamol is effective as the primary analgesic drug in post-cardiac surgery patients up to 3 years of age and that the use of IV paracetamol will reduce overall morphine requirements.
Introduction and Objective: In recent years, 3D (three-dimensional) modeling has been added to traditional and effective diagnostic methods such as Computed Tomography (CT), Magnetic Resonance Imaging (MRI), and Echocardiography. The purpose of this study is to determine the effectiveness of models created from patients' own radiological images using 3D printing technology in the clinical setting to simulate surgery in the preoperative period and provide preoperative parental education to improve family quality of life and positively influence patient outcomes. Methods: The study is a two-group pretest-posttest randomized controlled study. The children who come to the outpatient clinic examination in a private hospital and who are subjected to Computed Tomography (CT) examination for diagnostic procedures will be modeled in the experimental group, pre-tests will be applied, and the model will be 3D printed after it is approved by the radiologist who is among the researchers. The sample size is 15 experimental group and 15 control group. After the radiologist's approval, surgical simulation and preoperative education will be applied to the experimental group. The control group will receive the same parent education as the standard model. Both groups will complete the Sociodemographic Information Form, Surgical Simulation Evaluation Form - Part I, and Pediatric Quality of Life Inventory (PedsQL) Family Impacts Module one week prior to hospitalization. Surgical simulation and preoperative education will be completed on the same day. On postoperative day 0, only the Surgical Simulation Evaluation Form - Part II will be applied and on postoperative day 15, the Surgical Simulation Evaluation Form - Part II and the Pediatric Quality of Life Inventory (PedsQL) Family Impacts Module will be applied to both groups as a posttest. Pilot Study and Results: Modeling and 3D printing studies were conducted to carry out the study. A total of four diagnosed and treated patients were retrospectively analyzed. An intracardiac anomaly was detected in the patient data taken for the first model. It was decided to model the extracardiac structures since the inside of the heart was filled with blood, and the blood could not be ruled out as a solid structure. Finally, aortic coarctation was modeled clearly from the images taken and completed.
This research study is being done to provide comparative data to the Mayo Clinic Adult Congenital Heart Disease Registry.
Copenhagen Baby Heart Study - Impact (CBHS-I) is an extension to Copenhagen Baby Heart (CBH) which included over 25.000 new-borns in the Copenhagen area between 2016-2018. Based on clinical and subclinical deviations in the examinations in CBH, subgroups of participants will be invited to clinical examinations (echocardiography and electrocardiogram) in early childhood. There will also be a new, targeted inclusion based on certain exposures during pregnancy. The main objectives are to assess the prevalence of congenital and inherited heart disease and, and the development of these during early childhood; examining the association between pre- and postnatal exposure, disease, lifestyle, environmental and genetic factors; continue to establish reference values for echocardiography in Danish neonates and children.