View clinical trials related to Heart Defects, Congenital.
Filter by:"Fearless Physical Activity" are fun, physical literacy events where people with congenital heart disease (CHD) and sport/recreation leaders can do community-based sport/recreation opportunities "without fear" (i.e., appropriate for their health). Ontarians with CHD are a large and rapidly growing population;1% of children are born with CHD, adding 1,440 new children/year to the 113,900 Ontarians of all ages who are living with CHD. 'Fearless' will target CHD children, youth or adults, while encouraging family-based participation. During each season, the investigators will offer a one-day event for each age group (children, youth, adults) in each region of Ontario (4 seasons x 3 age groups x 4 regions = 48 events). Event activities will be hosted by community partners, such as the MLSE Launch Pad (Toronto) or the YMCA/YWCA of the National Capital Region (Ottawa), so that they are sustainable beyond this project. Activities will be chosen based on opportunities available in local communities at little to no cost (e.g., use of local trails and parks). Event leaders and participants will be educated about physical literacy and screening tasks will be used to identify those needing significant or specialized physical literacy support. People with CHD lead mostly sedentary lives. They are much less active than their friends and colleagues, even when their heart disease is mild, and inactivity can contribute to a higher risk for heart attacks, stroke, obesity, and depression. Uncertainty about physical activity, even though it is recommended (American Heart Association, May 2014), is an important barrier to the physical and mental health benefits of physical activity. "How much is too much?" and "Will it be too much for my heart?" are top-of-mind. "Fearless Physical Activity" will provide children, youth and adults living with CHD with new physical activity experiences and opportunities to enhance their physical literacy so they are better able to be "active for life".
This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market setting.
The Prosthesis-to-Annulus Relation I (PAR I) trial is a German multicenter study assessing the relation between the prosthetic GOA and the area of LVOT as potentially new parameter for the prediction of hemodynamic outcome. The results may possibly guide future valve size selection an may allow prediction of functionally relevant PPM (Patient-Prosthesis-Mismatch)
This study is to assess whether a lifestyle intervention with diet, exercise and counselling in young patients will have a positive influence on their weight and overall well-being. This study will enrol patients between the ages of 7 to 17 years of age, who have congenital heart disease, and have been identified being overweight or obese. A total of 40 individuals will participate in this study. The study duration will last for 1 year.
The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV.
The objective of this study is to use of STIC technology to assist the traditional echocardiography to diagnose the fetal congenital heart disease accurately and then to provide a basis for prenatal counseling.
The aim is to conduct a prospective multi-centre international inception cohort study with an enrollment goal of 3,000 TOF patients and 2 year follow-up post-repair. The proposed sample size and methodology will result in statistically powerful results to allow for evidence-based change to current TOF surgical practices.
The purpose of our study is to validate the accuracy of 4D PC flow method in quantification of thoracic and upper abdominal blood flow volumes in children. In this validation study, 4D PC flow method will be applied in 100 pediatric patients undergoing clinically indicated CMR with 2D PC flow measurement.
Rationale: Adult patients with congenital heart disease (CHD) with atrial tachyarrhythmias need to be anticoagulated. It is not known whether non-vitamin K antagonist oral anticoagulants (NOAC) in this patient group are efficient and safe. Aim: The purpose of the NOTE registry is to evaluate the efficacy and safety of NOACs for thromboembolic prevention in atrial tachyarrhythmias in adult patients with congenital heart disease (CHD). Methods: In this multicenter prospective registry adult CHD patients with atrial tachyarrhythmias on NOACs (switch from VKA or new on anticoagulants) will be followed for a minimum of two years. Primary efficacy endpoints are defined as thromboembolism, i.e. the composite of ischemic stroke, systemic and pulmonary embolism and intracardiac thrombosis, and as the composite of stroke and systemic embolism. Primary safety endpoint is defined as major bleeding according to the ISTH criteria. Secondary endpoints include each thromboembolic or bleeding event analysed separately, all-cause mortality, therapy adherence, quality of life, risk assessment of stroke and evaluation of natural history of atrial tachyarrhythmia in adult CHD patients. Primary endpoint assessment will be performed with a per protocol analysis, and demonstrated as Kaplan Meyer estimates of event free survival and event rates per year.
Congenital heart defects are seen in 0,8% of life births. In France this means more than 5000 newborns per year. The south-east region of France is particularly affected as a result of a higher birth rate and consanguinity, when compared to other regions. The majority of congenital heart diseases remain unexplained. Genetic causes are indisputable but remain poorly understood. Genetic research needs the availability of a large-scale DNA collection, guided by a robust phenotypic classification. Such a DNA-bank has been created in Paris (CARREG DNA bank, created by the M3C reference centre for congenital heart diseases). Such a bank is currently unavailable in south-east France. To transport biological specimens from Marseille to Paris would be very expensive. In addition, the whole infrastructure required for correct diagnosis and classification of the congenital heart diseases, for sampling, for storage of the samples and genetic analysis, does exist in our AP-HM hospital and in our AMU research unit. For those reasons it is highly preferable to elaborate such a database and DNA-bank locally. The acronym SEA-HD (South-EAst-Heart-Diseases) would be used to name this DNA-bank