View clinical trials related to Heart Defects, Congenital.
Filter by:This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).
Ventricular septal defects (VSD) are the most common cardiac congenital heart defect (about 1/3 of patients with congenital heart disease). VSD management is related to hemodynamics and anatomical localization and the occurrence of complications. Small perimembranous VSD without pulmonary hypertension and without significant left to right shunting are tolerated, whereas large VSD with pulmonary hypertension require early surgical management in the first months of life. The management uncertainties concern the medium-sized perimembranous VSD causing a significant left-right shunt but without pulmonary hypertension, which are of variable treatment (surgical correction, percutaneous treatment, medical or abstention). There are no recommendations or consensus on the preferred indication of a therapeutic attitude. The Pediatric and Congenital Cardiology Subsidiary, within the French Society of Cardiology, set up an observatory of perimembranous VSD with significant shunting, without pulmonary hypertension the objectives of this study are: - To study the incidence of cardiovascular events in perimembranous VSD and search for predictive anatomical markers of events. - To study the evolution of echocardiographic and functional data of patients having percutaneous or surgical closure compared to patient managed medically. This observatory will provide a better understanding of the therapeutic algorithm in the management of VSD with pulmonary overload without pulmonary hypertension.
A nationwide observational study. Children operated with single-ventricle palliation between January 1994 and December 2017 operated in Sweden will be included retrospectively. Patients born with a functionally single ventricle but not undergoing surgery will not be included. Data regarding preoperative clinical characteristics and operative details will be obtained by medical records review and from The Swedish Registry of Congenital Heart Disease (SWEDCON). Using unique personal identity numbers assigned to all residents of Sweden, data from SWEDCON will be linked with dates of death.
Background: Congenital heart disease (CHD) is one of the most common congenital anomalies in children. As the risk for endocarditis following bacteraemia is more common during daily oral hygiene routines, such as tooth brushing, than during dental treatment, the maintenance of optimal oral health in children with CHD may be considered of outmost importance. Children with CHD have a higher caries prevalence compared to healthy controls. Aim: The primary aim of the study is to explore if an educational intervention including information, counselling and support provided at early stage to families affected by major CHD, or CHD combined with a syndrome, can increase the awareness of the importance of maintaining of good oral health, and avoid the development of poor oral health including dental caries, leading to less dental anxiety and a higher oral heath related quality of life. The secondary aim is to elucidate factors associated with the development of poor oral health and/or orofacial dysfunction as well as family attitudes and needs of support. Hypothesis: Early information, counselling and support will lead to a) increased awareness of the importance to maintaining good oral health, b) prevent the development of poor oral health and dental caries, c) lead to less dental fear, and d) lead to higher oral heath related quality of life. Study design: Randomized educational intervention trial. Study population: Children born in Finland and under 12 months of age in 1.7.2017-31.12.2021 with, a) major CHD and potentially included in the criteria of endocarditis prophylaxis, or b) with a major CHD combined with a chromosomal syndrome, will be offered to participate in the study. Patients will be recruited until 200 patients are obtained at the Helsinki University Children's Hospital. A control group consisting of approximately 100 healthy children will also be recruited at birth. Main outcomes: Dental caries, dental anxiety, oral health related quality of life, and awareness of importance to maintain and behaviour to maintain good oral health. Significance: Better information to patients leads to better possibility to achieve good oral health. Better oral health leads to 1) less dental procedures and thereby less dental anxiety, 2) less dental procedures under general anaesthesia, which may potentially be a risk procedure for the child with CHD, and 3) better oral health related quality of life.
The study looks to learn more about the helpfulness of web-based transition education and its effect on transition readiness and health service utilization in the adolescent and young adult congenital heart disease population.
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR). Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction.
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 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.
This study will explore new ways of using magnetic resonance imaging (MRI) to evaluate pediatric patients with cardiovascular disease,congenital heart disease in patients of all ages, fetuses undergoing clinically indicated MR imaging.