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Heart Defects, Congenital clinical trials

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NCT ID: NCT03431480 Not yet recruiting - Clinical trials for Heart Defects, Congenital

Safety of Autologous Cord Blood Cells in HLHS Patients During Norwood Heart Surgery

Start date: February 26, 2018
Phase: Phase 1
Study type: Interventional

This study aims to evaluate the safety and feasibility of coronary infusion of autologous placental cord blood mononuclear cells during the Norwood heart operation in newborn hypoplastic left heart syndrome (HLHS) patients.

NCT ID: NCT03417999 Not yet recruiting - Clinical trials for Congenital Heart Disease

Pharmacokinetic Study of Intranasal Dexmedetomidine in Pediatric Patients With Congenital Heart Disease

Start date: February 2018
Phase: Phase 1
Study type: Interventional

The main objectives of the study are to determine peak plasma drug concentration levels and corresponding time of dexmedetomidine following intranasal administration in children age ≥1 mo to ≤ 6 yr with congenital heart disease undergoing an elective diagnostic or interventional cardiac catheterization procedure.

NCT ID: NCT03411512 Completed - Clinical trials for Heart Defects, Congenital

Congenital Heart Defects and NIRS

Start date: December 1, 2012
Phase: N/A
Study type: Observational

Congenital Heart Defects and NIRS

NCT ID: NCT03405636 Not yet recruiting - Clinical trials for Heart Defects, Congenital

Xeltis Pulmonary Valved Conduit Safety and Performance Study

Start date: April 2018
Phase: N/A
Study type: Interventional

This is a multi-center prospective, single-arm, non-randomized, open label study to assess safety and performance of the Xeltis Pulmonary Valved Conduit in subjects requiring Right Ventricular Outflow Tract correction or reconstruction due to congenital heart malformations.

NCT ID: NCT03379831 Recruiting - Clinical trials for Congenital Heart Disease

Correlation Between Quality of Life and Aerobic Physical Fitness of Patients With a Systemic Right Ventricle

Start date: February 2018
Phase: N/A
Study type: Observational

Congenital heart disease (CHD) is the most common congenital malformations. The right ventricle in the sub-aortic position, or "systemic right ventricle" is one of these complex cardiac diseases. Several studies show that adults with CHD and especially systemic right ventricle have reduced exercise capacity. In addition, studies have shown that there is a correlation between alteration of aerobic physical capacity and alteration of right ventricular systolic function. Understanding and assessing the determinants of the physical capacity of patients with systemic right ventricles and evaluating their quality of life could allows us to improve their therapeutic management and also to expand patient indications to a program cardiac rehabilitation. This can benefit them on their exercise capacity, their tolerance to exercise and their quality of life. The aim is to study the correlation between the quality of life and the aerobic physical fitness of patients with a systemic right ventricle and to determine the clinical and paraclinical parameters that have an impact on the aerobic physical fitness of these patients. The quality of life of patients with a systemic right ventricle will be compared to that of the general population.

NCT ID: NCT03366597 Recruiting - Clinical trials for Congenital Heart Disease

The Research of the Effect of Sevoflurane on Brain-protection of Cardiac Surgery in Infants.

Start date: December 20, 2017
Phase: N/A
Study type: Interventional

To observe the effect of sevoflurane on the concentration of S100β and regional cerebral oxygen saturation in infants with congenital heart disease undergoing cardiac surgery.

NCT ID: NCT03363932 Not yet recruiting - Clinical trials for Congenital Heart Disease

French Observatory of Congenital Ventricular Septal Defect With Pulmonary Overload

FRANCISCO
Start date: January 2018
Phase: N/A
Study type: Observational

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.

NCT ID: NCT03361189 Not yet recruiting - Clinical trials for Congenital Heart Disease

Specialized Pacing for Patients With Congenital Heart Disease

Start date: February 1, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

The closed-loop stimulation (CLS) algorithm is a novel sensor-based technology that relies on the change in myocardial systolic impedance for modulation of the heart rate during physical and emotional stress.3 The pacing algorithm has been shown to be highly effective for a wide range of clinical scenarios. Despite the fact that congenital heart disease (CHD) patients are likely to derive significant benefit in terms of functional ability and aerobic capacity using this novel technology, the CLS system has not been adequately studied in this population. As many CHD patients also undergo epicardial placement of pacing systems at the time of concomitant cardiac surgery, CLS has been less often utilized in this population given almost no data in the setting of surgical electrode placement. The present study intends to examine the benefits of the CLS algorithm in the CHD population, employing the use of epicardial pacemaker systems in the study protocol.

NCT ID: NCT03360370 Not yet recruiting - Clinical trials for Congenital Heart Disease

Neurodevelopmental Disorders in Children With Congenital Heart Disease

NeuroDis-CHD
Start date: December 2017
Phase: N/A
Study type: Observational

Children with congenital heart disease are at risk for neurodevelopmental disorders, these disorders impacting their quality of life and their integration into society. The aim of this study is to detect neurodevelopmental disorders in children (aged from 6 to 66 months) with congenital heart disease in Nord-Pas-De-Calais (France) and to evaluate the frequency and risk factors of these neurodevelopmental disorders for a better follow-up. This study will help implementing a specific program for the evaluation and management of neurodevelopmental disorders in children suffering from congenital heart disease in Nord-Pas-De-Calais and more globally, in the region Hauts-De-France.

NCT ID: NCT03356574 Active, not recruiting - Clinical trials for Heart Defects, Congenital

Long-term Survival After Single-ventricle Palliation

Start date: January 1, 1994
Phase: N/A
Study type: Observational

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.