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Heart Defects, Congenital clinical trials

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NCT ID: NCT02432079 Recruiting - Clinical trials for Congenital Heart Defects

Molecular Genetics of Heterotaxy and Related Congenital Heart Defects

Start date: July 2009
Phase:
Study type: Observational

The goal of this study is to obtain specimens and data from individuals and their families with heterotaxy and related congenital heart defects in order to clarify the molecular genetics of this disorder. The knowledge gained from the analysis of this information will provide the basis for future genetic counseling as well as contribute to knowledge about the biology of normal and abnormal development of left-right anatomic asymmetry.

NCT ID: NCT02417259 Completed - Clinical trials for Congenital Heart Defects

Near Infrared Spectroscopy in Cyanotic Congenital Heart Disease

Start date: July 2015
Phase:
Study type: Observational

We are conducting a prospective cohort study of 20 children with cyanotic congenital heart disease who are admitted for cardiac surgery. We will record cerebral and somatic near infrared spectroscopy (NIRS) at two sites - forehead and flank regions using the Covidien INVOS™ 5100C Cerebral / Somatic Oximeter. The monitoring will begin one hour pre-operatively (baseline) and continue until 48hours post-operatively. We will also take measurements prior to discharge from hospital. Baseline demographics, physiological and laboratory variables will be recorded. Clinical outcome variables including mortality, duration of intensive care unit (ICU) stay, duration of mechanical ventilation, inotropic support and feed tolerance will also be recorded.

NCT ID: NCT02414321 Recruiting - Clinical trials for Congenital Heart Disease

The Role of the Pulmonary Vasculature in the Fontan Circulation

Start date: June 2015
Phase:
Study type: Observational

This study aims to explore the structural and functional characteristics of the pulmonary vasculature in adult Fontan patients. Objectives: - Determine the effect of pulmonary vasodilatation on indexed cardiac output during simulated exercise. - Characterization of structural properties of small pulmonary arteries.

NCT ID: NCT02410473 Active, not recruiting - Clinical trials for Congenital Heart Disease

Evaluation of Coagulation Testing in Patients Undergoing Cardiac Surgery

Start date: April 2015
Phase:
Study type: Observational

Neonates, children with single ventricle congenital heart disease, and those undergoing multiple complex cardiac surgeries are at high risk of increased perioperative blood loss, and blood product transfusions. In addition, some of these patients will present an increased risk of postoperative thromboembolic complications. For a long time, bleeding management has been based on the empiric administration of different blood products (e.g. platelet concentrates, cryoprecipitates, and/or activated factor VII), topical hemostatic agents, and surgical manipulation. Recently, the use of viscoelastic tests (e.g. thromboelastography (TEG) or thromboelastometry (ROTEM)) increased, and allowed a better assessment of perioperative coagulopathy, and a more 'rational' treatment of bleeding. While TEG and ROTEM record the viscoelastic properties of whole blood by measuring mechanical impedance and related changes during clot formation, T2MR, a miniaturized, magnetic resonance-based diagnostic platform, measures how water molecules react in the presence of magnetic fields to evaluate a broad range of hemostasis measurements. In this study, we will prospectively collect demographic data, surgical characteristics, the amount of perioperative bleeding and blood product transfusion, results of laboratory assays, and postoperative outcomes (30-day follow-up or until discharge), with the aim to assess our current practice, and develop an algorithm-based approach for the administration of targeted blood product and pro-coagulant therapies. Our goals are: the reduction of blood product utilization, the reduction of the incidence of massive bleeding and postoperative thrombosis.

NCT ID: NCT02409706 Completed - Clinical trials for Heart Defects, Congenital

Micronutrients in Children in Critical Care With Cardiac Conditions

MC5
Start date: August 2014
Phase: N/A
Study type: Observational

This study aims to explore the frequency and types of micronutrient deficiencies in a sample of UK children with CHD using standard and novel markers in blood. The study will also explore whether micronutrient deficiencies increase the risk of complications after heart surgery. This study will identify any nutrient deficiencies that need monitoring in clinical practice.

NCT ID: NCT02395276 Not yet recruiting - Child Clinical Trials

Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit for Suspected for Brain Injury

Coolheart
Start date: April 2015
Phase: N/A
Study type: Interventional

Cardiac pathology is a major risk for brain injury and neurodevelopmental deficit. The most common cause of cardiac pathology is congenital heart defects (CHD) about 4-8/1000 live births a year. The most common etiology of the brain insult is hypoxic ischemic injury (HII) as result of hemodynamic instability in the perioperative period. Similar insults in adults with cardiac arrest or infants with neonatal asphyxia, was successfully treated with hypothermia, initiated within 6 hours after the event. Although, hypothermia is most likely an effective treatment for HII in children with cardiac anomaly, it also carries a risk for bleeding or infection of the surgical wound. In this randomized control trial, hypothermia treatment will be compared to normothermia treatment of patients in the pediatric cardiac intensive care unit (PCICU) following severe HII in the PCICU or operating room. The effect will be quantified by MRI, serum biomarkers of brain injury, amplitude integrated EEG, neurological evaluation coagulation and infection evaluation in the acute phase and by developmental assessment at 1, 6 months and 2, 5 years. Favorable effect of hypothermia with minimal risks may open the door for the implementation of hypothermia as a standard care in PCICUs.

NCT ID: NCT02389491 Completed - Clinical trials for Congenital Heart Disease

Effect of a High Density Formula on Growth and Safety in Congenital Heart Disease Infants

CHD
Start date: March 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to explore the effects of high density formula in early postoperative infants with congenital heart disease and to assess its safety.

NCT ID: NCT02387944 Completed - Clinical trials for Congenital Heart Defect

Bedside Evaluation of Coagulation in Children With Congenital Heart Disease

POCHEMO
Start date: March 2015
Phase: N/A
Study type: Observational

The purpose of this study is to assess coagulation and platelet function in children with congenital heart disease, measured with a bedside device (thromboelastometry and impedance aggregometry). The investigators also aim to determine if this device detect post-cardiopulmonary bypass clotting derangements and may help to manage bleeding in this population.

NCT ID: NCT02377700 Completed - Clinical trials for Heart Defects, Congenital

Safety and Performance of a Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis

XEL-CR-06
Start date: June 2014
Phase: N/A
Study type: Interventional

Xeltis developed biodegradable patch prosthesis, the Vascular Patch Model COR-VP-001, to be used as a vascular patch to augment the pulmonary trunk and pulmonary arteries. The prosthesis is immediately mechanically functional, while its physiochemical characteristics should enable cell infiltration and tissue formation. The Xeltis Vascular Graft Model COR-VP-001 is specifically designed to improve surgical outcomes by reducing synthetic material related complications and improving hemodynamic characteristics.

NCT ID: NCT02377674 Completed - Clinical trials for Heart Defects, Congenital

Safety and Performance of the COR-VG-001 Conduit in Pediatric Patients for Extracardiac Total Cavopulmonary Connection

EC-TCPC
Start date: October 2013
Phase: N/A
Study type: Interventional

The extracardiac Fontan surgery/procedure involves diverting the venous blood from the inferior vena cava to the pulmonary arteries without passing through the morphologic right ventricle. In the extracardiac conduit type of Fontan, one end of a synthetic tube graft is connected to the inferior vena cava and the other end to the pulmonary artery confluence. Xeltis developed a biodegradable prosthesis, the Xeltis Vascular Graft Model COR-VG-001, to be used as an extracardiac conduit between right atrium and the pulmonary arteries. The prosthesis is immediately mechanically functional, while its physiochemical characteristics should enable cell infiltration and tissue formation. The Xeltis Vascular Graft Model COR-VG-OO is specifically designed to enhance the Fontan surgery outcome by reducing synthetic material related complications and improving hemodynamic characteristics.