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Heart Defects, Congenital clinical trials

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NCT ID: NCT03063801 Completed - Clinical trials for Congenital Heart Defect

Study on the Transfusional Management of the Patients With Congenital Heart Disease Carried Out in Adulthood.

Start date: April 1, 2017
Phase: N/A
Study type: Observational

Surgeries of heart disease in adulthood can happen in two specific contexts: - either for an asymptomatic anomaly, possibly coupled with the onset of symptoms later in life and tardily diagnosed and surgically managed - either for a malformation treated in childhood and requiring a new intervention in adulthood. In recent years, the number of adult patients with congenital heart disease has been steadily increasing. Advances in diagnostic techniques and surgical treatments have enabled many children to reach adulthood. The number of these patients is now higher than the number of children with congenital heart disease. The number of these patients having had surgery in adulthood is also increasing. Congenital cardiopathies are numerous, ranging from simpler pathologies such as inter-auricular or inter-ventricular communication, to much more complex pathologies such as situations of univentricular hearts. The surgical treatments of these congenital heart diseases are classified into three groups: initial palliative surgery, initial curative surgery or iterative surgery. Palliative surgery aims to improve the clinical tolerance of the patient to the conditions of his pathology or to prevent complications. The curative surgery restores the physiological circulation, the iterative surgery treats a complication or a degeneration appearing after a curative surgery. Patients undergoing cardiac surgery frequently receive blood products transfusions during the preoperative, intraoperative, or postoperative periods. Several observational studies have shown that in cardiac surgery, the transfusion of blood derivatives is associated with an increase in post-operative morbidity and mortality. The objective of this study is to analyze the predictive factors of transfusion in congenital patients operated in adulthood at Brugmann University Hospital, depending on the type of surgery applied (palliative, curative or iterative). The secondary objective will be to assess whether there are any differences with the predictive factors identified in non-congenital patients undergoing cardiac surgery, which could potentially alter the transfusion approach in congenital patients.

NCT ID: NCT03050112 Completed - Clinical trials for Congenital Heart Disease

Long-term Quality of Life of Patients With a Congenital Heart Disease, Treated by Surgery in Adulthood at the Brugmann Hospital.

Start date: February 14, 2017
Phase: N/A
Study type: Interventional

Adults with a congenital heart disease, having undergone a surgical intervention or a re-do surgery in adulthood, are a growing group of subjects in the general population. This increase is explained by improved medical and surgical techniques, with a better survival rate as outcome. There is nowadays a growing interest in the quality of life of this group of subjects. However, studies give contradictory results. This can be explained on one hand by the vast majority of pathologies within this population, and on the other hand by the absence of a cardio-specific tool for quality of life measurement. The MacNew questionnaire is cardio-specific. It allows an evaluation of the quality of life based on the exploration of three domains: physical, emotional and social. The aim of this study is: - to evaluate the quality of life of these patients, by using the MacNew questionnaire - to explore the needs in terms of prevention, treatment and multi-disciplinary follow-up - to assess the mortality within this group of patients.

NCT ID: NCT03049540 Completed - Clinical trials for Heart Defects, Congenital

Effect of Phosphodiesterase-5 Inhibition With Tadalafil on SystEmic Right VEntricular Size and Function

SERVE
Start date: October 25, 2017
Phase: Phase 3
Study type: Interventional

This study assesses in a double-blind, randomized, placebo-controlled multi-center pilot trial the effect of PDE-5 inhibition with Tadalafil on right ventricle size and function, exercise capacity and neurohumoral activation in adults with congenital heart disease and a right ventricle in subaortic position over a 3-year follow-up period.

NCT ID: NCT03047343 Completed - Clinical trials for Congenital Heart Malformations

Evolution of Two Cohorts of Children (Univentricular and Bi-ventricular Heart) After Strapping of the Pulmonary Artery

Start date: March 1, 2017
Phase:
Study type: Observational

Pulmonary artery strapping is a surgical technique aimed at providing a palliative treatment to newborns suffering from congenital heart defects, characterized by an increase in blood flow and pulmonary blood pressure. The intervention consists of placing a band around the pulmonary artery. This band causes an artificial stenosis, therefore inducing a reduction of the pulmonary arterial pressure. It acts as a first step, preparing the ground for a future definitive repair intervention. It is mainly used in the context of septal defects, atrio-ventricular canal defects or uni-ventricular hearts. The complications linked to strapping include, among others, the erosion of the band in the artery lumen, its migration and the obstruction of the pulmonary artery, a pulmonary valvular insufficiency, the obstruction of the coronary artery and an ineffective strapping. The early mortality rate of pulmonary artery strapping after 1980 varies between 1.8% and 13.6%, while strapping readjustment rates oscillate around 20%. It is assumed that the mortality is linked to the nature of the cardial malformation (uni-ventricular or bi-ventricular) rather than the procedure itself. This retrospective study aims to evaluate the intra-hospital and extra-hospital mortality rate of pulmonary artery strapping, as well as the readjustment rate within two groups of patients: those benefiting from an uni-ventricular cardiac reparation and those benefiting from a bi-ventricular cardiac reparation. The aim is to determine the short term mortality rate of the intervention and the incidence of complications within the hospital, within the two groups.

NCT ID: NCT03035552 Completed - Clinical trials for Heart Defects, Congenital

CTICU Pacifier Activated Music Player and Mother's Voice

Start date: September 15, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if intensive training of Non-Nutritive Suck (NNS) using contingent positive reinforcement with mother's voice can improve the feeding outcomes of infants with congenital heart defect (CHD) at high risk for oral motor problems.

NCT ID: NCT03023644 Completed - Children Clinical Trials

Improving Neurodevelopmental Outcomes in Children With Congenital Heart Disease: An Intervention Study

Start date: February 21, 2017
Phase: N/A
Study type: Interventional

Each year, approximately 1 child in every 100 is born with Congenital Heart Disease (CHD), making it the most common birth defect. With recent medical advances, more children with CHD survive early open-heart surgery, so that there are now 2 to 3 million adult survivors with CHD. These survivors face challenges in terms of their cognitive and behavioral development. For many, the limitations affect their academic achievement, social adaption and, ultimately, their quality of life. Among the most disabling limitations are those that pertain to the ability to maintain attention, plan and organize activities, regulate emotions, and develop problem-solving strategies. Collectively, these are referred to as executive functions (EF) because they are higher-order abilities that enable one to coordinate complex behaviors. Additionally, impaired EF also underlie mental health disorders. In spite of the abundance of evidence that children with CHD struggle with EF, there is little to offer them in the way of evidence-based interventions to prevent or mitigate these problems. The investigators propose to conduct the first randomized trial to evaluate the efficacy of an intervention, the Cogmed Working Memory Program, in improving the neurodevelopment outcomes of children with critical CHD after infant open-heart surgery. Children who meet eligibility criteria and who agree to participate will be randomly assigned to an intervention or control group. Children in the intervention group will complete 25 35-40 minute sessions of Cogmed training, spread over for 5 weeks. This Program is a set of home-based, child-friendly, computerized activities. The control group will receive the standard of care for children with CHD. Children's scores on EF and related neurodevelopmental tests will be evaluated before the intervention group completes Cogmed training, at the conclusion of their training, and 3 months later. The latter assessment will indicate whether any gains in EF skills of the children in the intervention group are sustained after training. Parents and teachers will also complete questionnaires about children's EF, attention, and social behaviors to determine whether training affects behaviors of the intervention group at home and in school. The investigators will also identify the medical and surgical characteristics of children who benefit most from Cogmed training. This information will be helpful in targeting the intervention most efficiently in the future.

NCT ID: NCT03022708 Enrolling by invitation - Clinical trials for Heart Defect, Congenital

Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study

Xplore2
Start date: May 8, 2017
Phase: N/A
Study type: Interventional

This is a multi-center prospective, single-arm, non-randomized, pivotal study that will continue to access the feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring right ventricular outflow tract correction or reconstruction due to congenital heart malformations.

NCT ID: NCT03005626 Completed - Clinical trials for Congenital Heart Diseases

Transition From Adolescents to Adulthood for Patients With Congenital Heart Diseases

Start date: January 2017
Phase: N/A
Study type: Interventional

The Investigators aim to measure the impact of a transition program in congenital cardiology in terms of health-related quality of life.

NCT ID: NCT02996630 Recruiting - Clinical trials for Congenital Heart Disease

Assessing Neurodevelopment in Congenital Heart Disease.

NEUROHEART
Start date: May 2013
Phase: N/A
Study type: Interventional

Congenital heart disease (CHD) is the most prevalent congenital malformation affecting 1 in 100 newborns per year. Children with CHD are a known risk population for brain injury, with neurodevelopmental alterations shown over time in up to 50% of cases. No adequate description exists of the type of neurocognitive anomalies or risk factors associated with CHD, and consequently no prognostic markers that may allow identification of high-risk cases are available.

NCT ID: NCT02995577 Recruiting - Clinical trials for Single Ventricle Physiology

Biomarkers for Feeding Intolerance in Infants With Complex Congenital Heart Defects Undergoing Single Ventricle Staged Palliation

Start date: December 2016
Phase: N/A
Study type: Observational

The purpose of this study is to investigates serum and stool biomarkers as predictors for post-operative feeding intolerance in infant patients with complex congenital heart defects who undergo single ventricle staged palliation surgery.