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Showing 1-20 of 222 trials
NCT07546227
This study is a single center randomized controlled trial evaluating the effect of an exercise training intervention (interval training or moderate continuous training) compared to usual care (no training) on exercise capacity in patients with congenital heart disease (CHD). Our primary aim is to determine the impact of interval training (IT) compared to moderate continuous exercise training (MCT) versus controls (no exercise) on exercise capacity as measured by peak VO2. Secondary aims are to: 1) assess the safety of exercise training in CHD, 2) evaluate the effect of exercise training on cardiac structure and function and 3) assess the effects of exercise training on quality of life and long-term physical activity.
NCT07526662
This is a prospective observational cohort study conducted at Beijing Anzhen Hospital. The study aims to establish reference ranges of heart sound and electrocardiogram (ECG) parameters for both mothers and fetuses. It seeks to develop early warning models for maternal adverse cardiac events, fetal congenital heart disease progression, and autoimmune-related fetal heart block, thereby building a comprehensive maternal-fetal integrated risk stratification system.
NCT06918795
The goal of this randomized control trial is to learn about physical fitness and exercise habits in children aged 10-17 with the Fontan Circulation through a home-based, digital exercise intervention. The main questions it aims to answer are: * Does a home-based, digital intervention increase physical activity (PA) in youth with the FC compared to enhanced usual care? * Does a home-based, digital intervention increase physical fitness in youth with the FC compared to enhanced usual care? * Do multi-level factors (medical, neurodevelopmental, sociodemographic, neighborhood) impact the effectiveness of the digital intervention? Researchers will compare participants in the enhanced usual care arm to those in the exercise intervention arm to see if the digital intervention is effective. All participants will wear a PA tracker for 12 months and complete testing at baseline, 6 months, and 12 months. In addition, participants in the exercise intervention arm will complete a 6-month exercise intervention with the following components: * aerobic exercise * resistance exercise * engagement strategies
NCT06193863
This is an observational study in which the data from children with congenital heart disease will be collected and studied. These children will include those who are prescribed rivaroxaban by their doctors after a heart surgery called the Fontan procedure. Congenital heart disease (CHD) is a heart problem that some children are born with. It sometimes requires a surgery called the Fontan procedure to improve the blood flow in the body. The Fontan procedure can increase the risk of the formation of blood clots in the blood vessels (called thrombosis), which might lead to death. The study drug, rivaroxaban, is an approved treatment for preventing the formation of blood clots. It is a type of anticoagulant that prevents the blood from clotting by blocking a protein responsible for it. Rivaroxaban can increase the risk of bleeding. A previous study suggested that the number of major bleeding episodes did not differ much while taking rivaroxaban compared to aspirin in children with CHD who had undergone the Fontan procedure. However, there is limited information available for Japanese patients. To better understand the safety and potential risks of this drug in children, more knowledge is needed about the use of rivaroxaban in the real world. The main purpose of this study is to learn more about the occurrence of major bleeding or non-major bleeding in children who were treated with rivaroxaban. Major bleeding is defined as a serious or life-threatening bleeding episode that can have an impact on a person's health and requires medical attention. Non-major bleeding is defined as a type of bleeding that may negatively impact a person's health if not treated. The data will be collected from December 2023 to June 2026. Researchers will observe each participant for up to 30 days after stopping the treatment or for a maximum of 2 years. In this study, only available data from regular health visits will be collected. No visits or tests are required as part of this study. Researchers will use the medical records or interview the children and/or their guardians during regular visits.
NCT07486167
The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial in children undergoing biventricular repair of their congenital heart disease (CHD) with cardiopulmonary bypass. Main hypotheses: Does a standardized PEEP-Titration maneuver, to optimize end-expiratory lung volume improve: * cardiac performance * lung function Does it make a difference in: * length of ventilation * ventilation/perfusion mismatch of the lung * need for vasopressor support?
NCT07481565
The goal of this clinical trial is to test the results of a protocoled speech therapy online intervention in children with congenital heart disease aged between 0 and 12 months old, who feeds tube only. The main questions it aims to answer are: * Does this online protocoled intervention helps to improve milk volume consumed by the babies though oral intake? * Does the ability to swallow improves by this online speech therapy approach? Participants will be evaluated on a video call by a blinded speech therapist and will receive 10 days online intervention by the speech therapist researcher who has 10 years expertise on this population. At the end of the 10 days intervention, they will be evaluated once more by the blinded speech therapist. Researchers will compare intervention and no intervention groups to see if there is any improvement on the oral intake volume of milk taken orally by the baby and if there is improvement on the ability of swallowing.
NCT07479654
The goal of this three-year mixed-methods observational study with an embedded randomized controlled trial is to develop and validate a frailty risk prediction model and evaluate an artificial intelligence-based voice emotion detection-guided counselling intervention in adults with congenital heart disease (ACHD). The main questions it aims to answer are: Are symptom clusters associated with frailty and psychological outcomes in adults with congenital heart disease? Can symptom clusters and psychosocial factors be used to predict frailty risk over time in ACHD patients? Does an AI-based voice emotion detection-guided counselling intervention improve psychological outcomes, fatigue, and quality of life among high-risk ACHD patients? Researchers will compare ACHD patients receiving AI-based voice emotion detection-guided counselling with those receiving usual care to determine whether the intervention reduces depression, anxiety, sleep disturbance, fatigue, and frailty risk, and improves grit and quality of life. Participants will: Complete longitudinal assessments of symptom clusters, frailty, and psychological status at baseline and follow-up time points Participate in qualitative interviews to explore lived experiences related to symptoms and frailty Receive AI-based voice emotion detection-guided counselling (intervention group only in Year 3)
NCT07477197
A repository of biospecimens and detailed phenotypic information collected longitudinally from adults with congenital heart disease and related conditions, with an aim to facilitate future research on biologic mechanisms of underlying disease, compensation and deterioration; biologic correlates of patient experience and functional status; associations between clinical characteristics and various biomarkers; and predictors of clinical outcomes.
NCT04463446
Congenital heart disease (CHD) survivors constitute one of the fastest growing populations in adult cardiology practices. This population is vulnerable to gaps in care, particularly as they graduate from the pediatric to adult healthcare system. Their healthcare needs are complex, and preparing this population for transfer to adult care is a resource-intense process. This trial will evaluate the use of the MyREADY Transition CHD app against a nurse-led one-time intervention in clinic. Participants will be 16-17 year olds who attend a cardiology outpatient clinic. The app will allow young adults to learn about their heart condition and about self-management skills in the context of adult healthcare by using the app for 18 months. The nurse-led intervention will cover similar topics, but in a one-time in-person session with a clinic nurse. Outcomes: The primary outcome is change in Transition Readiness Assessment Questionnaire (TRAQ) score over time. Secondary outcomes are change in the MyHeart Score and the General Self-Efficacy (GSE) score. These questionnaires will be answered by all participants at regular intervals (enrollment, 1 month, 6 months, 12 months, 18 months) throughout the trial. The trial will also consider time to the first adult cardiology appointment, cost of the interventions, and will conduct interviews with participants in the app group to learn about their experiences using the app.
NCT05647213
The goal of this clinical trial is to test the safety of lab-grown heart cells made from stem cells in subjects with congenital heart disease. The main questions it aims to answer are: * Is this product safe to deliver to humans * Is the conduct of this trial feasible Participants will be asked to: * Agree to testing and monitoring before and after product administration * Receive investigational product * Agree to lifelong follow-up Researchers will compare subjects from the same pool to see if there is a difference between treated and untreated subjects.
NCT07466745
Prospective, single-arm, multi-center, continued access study of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement. The Autus Valve may be expanded pre-implant to match the subject's body size. Subjects will be evaluated prior to the Autus Valve implant procedure, immediately post-implantation, at hospital discharge, 30 days, 6 months, and annually through 10 years. The Autus Valve may be expanded post-implant via transcatheter balloon dilation to accommodate growth of the subject.
NCT05610787
The purpose of this study is to evaluate the device performance and monitor the safety and effectiveness of the Berlin Heart EXCOR Active Driving System while being used with the approved EXCOR Pediatric Ventricular Assist Device. EXCOR Active Driving System is intended for use with the approved EXCOR Pediatric VAD. The EXCOR Pediatric VAD is intended to provide mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. Pediatric candidates with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support may be treated using the EXCOR Pediatric. EXCOR Active is intended for use in a clinical setting. EXCOR Active can be used in any kind of hospital unit (e.g. OR, ICU, intermediate care unit or general care unit). The driving unit may be moved between clinical units using the caddy or baby buggy; however, a patient must always be accompanied by a person trained in the use of the manual pump and emergency procedures during transport in the event of an emergency. The driving unit can be transported during operation.
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.
NCT07042334
This study involves testing a new video game designed to support adolescents with congenital heart disease (CHD) in preparing to manage their health independently. The game aims to teach essential skills such as communicating with healthcare providers, understanding medical information, and managing appointments and medications. This small pilot study will evaluate the game's usability, acceptability, and its impact on participants' confidence and preparedness for managing their heart care. Feedback will be collected from adolescent participants, their parents, and healthcare providers, and the study will examine how the game influences communication during clinical visits.
NCT05213598
Background: In Fontan Associated Liver Disease (FALD), congestion of blood in the liver causes cirrhosis. This condition can cause death. Researchers want to understand what triggers this process and find new treatments for it. Objective: To understand how long-term congestion of blood in the liver causes liver scarring that eventually leads to cirrhosis. Eligibility: People aged 18 and older who are at risk of developing FALD from the Fontan procedure. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Liver ultrasound. This uses sound waves to take pictures of the body. Participants will have an outpatient visit within 12 weeks after screening. Within 24 weeks later, they will have a 3-day hospital stay. About 2 weeks later, they will have a follow-up visit. Visits will include repeats of the screening tests and: Heart tests Stool collection Questionnaires MRI of the liver. Participants will lie on a bed that slides in and out of the scanner. They will receive a contrast agent injected into a vein. While in the scanner, they will also have an MRCP to view the bile ducts and the pancreatic duct. Fibroscan exam. This is an ultrasound that uses a special probe to look at the toughness of the liver. Upper endoscopy. This uses a thin scope to look inside the upper digestive tract. Liver biopsy. This will be taken through large vein in the neck or through the chest. Just before the biopsy, participants will have pressure measurements inside their liver. For this, a catheter will be inserted into a neck vein and guided into the liver.
NCT07118124
The purpose of this study is to see if the Zio® monitor device can be worn by children for up to 14-days and to determine if the skin preparation process will provide good adherence to the skin and clear signal quality. The Zio® monitor (Study Device) is an adhesive patch that is worn on the upper left chest for a specified period of time and is similar to a band aid. The Study Device contains a battery-powered heart monitor and will look at the heart rhythm and rate.
NCT06818760
Congenital heart disease (CHD) includes a wide variety of types of disease, including congenital abnormalities of the heart valves. This can range from bicuspid aortic valve and other aortic valve deformities to more complex disease such as tetralogy of Fallot. For many kinds of CHD, the optimal timing of interventions remains unclear. For instance, in tetralogy of Fallot, there is still equipoise about when to offer pulmonary valve replacement (PVR), while in aortic regurgitation, some patients can remain stable for many years. The primary focus of this study is to use continuous physiologic data (CPD), obtained using wearable biosensors (a type of biometric monitoring technology), to develop improved biomarkers of disease progression and prognosis from patients with congenital heart disease (CHD) who are pregnant while they are at home as well as looking at patients' experience and interaction with wearable biosensor technology at home.
NCT06932081
This real-world, international registry aims to evaluate the current experience with sodium-glucose cotransporter 2 inhibitors (SGLT2i) in adult congenital heart disease (ACHD) patients by investigating the prescription patterns, safety, tolerability, and potential beneficial effects on heart failure-related outcomes.
NCT06711666
Congenital heart disease (CHD) is the leading cause of congenital malformations, representing 1% of live births. Progress in surgical care have led to the dramatic increase in the population of children and adults living with heart disease. As survival is no longer a concern, long-term outcomes have become the major public health issue. Prenatal diagnosis of CHD requiring open-heart surgery can be a traumatic event for expecting mothers and fathers. In the general population, maternal mental health distress is associated with fetal disturbances in the hypothalamic-adrenal-pituitary system axis, restricted intrauterine growth and adverse outcomes in the offspring. It is unknown whether prenatal maternal psychological distress have an impact on neurodevelopmental outcomes in CHD. Our national study seeks to (1) characterize the impact of prenatal maternal psychological distress on neurodevelopmental outcomes at age 1 for children with CHD who undergo neonatal open-heart surgery; (2) investigate the sociodemographic and medical determinants associated with prenatal maternal mental health of women carrying a foetus diagnosed with complex CHD; (3) explore the mediating role of prenatal risk factors (i.e., sociodemographic, medical and maternal coping mechanisms) in the association of prenatal maternal mental health (i.e., distress, anxiety and depression) and neurodevelopment in children with CHD; and (4) explore the impact of paternal or the co-parent's mental health impact on neurodevelopmental outcomes at age 1 in children with CHD. This study is a non-interventional, prospective, and longitudinal study of prenatal maternal mental health and subsequent child's neurodevelopmental and behavioural outcomes. It includes a follow-up period from the 3rd trimester of pregnancy until the child's first year of life. It will include children with a prenatally diagnosed heart defect requiring open-heart surgery within the first weeks of life. Understanding and preventing the neurodevelopmental sequelae of heart disease diagnosed in-utero is a public health priority.
NCT04992793
Children born with congenital heart problems face numerous physical, developmental, and social challenges. Complications in pregnancy have potential to impair brain development, leading a smaller brain volume and less mature brain even in babies born at full term. As the brain is less mature, it may be more susceptible to oxygen deprivation and other forms of brain injury. Urgent surgery is often required in the first few weeks of life to improve functioning of the heart, but this surgery also carries a risk of additional brain injuries. The aim of this study is to provide a better understanding of factors associated with the development of brain injury in neonates undergoing heart surgery in the first year or life. The short-term aim of this study is to provide data to help our team to develop advanced monitoring software that can be used to guide perfusion of the brain during surgery with a view to preventing surgery-related brain injury. The mid-term goal of the study is to identify risk factors associated with brain injury and inflammation around the time of surgery, through using MRI and taking blood samples. A longer term aim of this study is to be able to follow the children as they develop to see if any problems develop later in life. In this study, we will ask parents to complete two brief questionnaires when their infant reaches 2 years of age. Overall, this study aims to improve our understanding of the causes of brain injury in patients born with congenital heart problems. The data provided by this study will help us to develop new tools for monitoring brain perfusion during surgery.