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Heart Defects, Congenital clinical trials

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NCT ID: NCT02374892 Completed - Clinical trials for Heart Defects, Congenital

The CHAPTER III Study of Young Adolescents

Start date: March 1, 2015
Phase: N/A
Study type: Interventional

The CHAPTER III Study (Congenital Heart Adolescents Participating in Transition Evaluation Research) is a cluster randomized controlled trial evaluating the impact of a nurse-led transition intervention in combination with usual care, versus usual care alone, on preparing adolescents with congenital heart disease (CHD) to successfully transition from pediatric to adult cardiology care. The Canadian Pediatric Society and American Academy of Pediatrics have recommended that transition interventions begin in early adolescence. Therefore, the investigators propose to conduct a nurse-led intervention that addresses the educational needs of 13-14 year olds.

NCT ID: NCT02358382 Recruiting - Clinical trials for Heart Defects, Congenital

The Management of Systemic-Pulmonary Collateral Blood Flow in Cyanotic Children During Cardiopulmonary Bypass - Pilot Study

Start date: March 2016
Phase: N/A
Study type: Interventional

The purpose of the study is to determine whether it is possible to manage the flow of blood through blood vessels using varying levels of carbon dioxide during cardiac surgery, and what effect this has on how well the major organs of the body work.

NCT ID: NCT02352662 Withdrawn - Clinical trials for Congenital Heart Disease

Peri-operative Assessment of Coagulopathy in Neonates and Infants Undergoing Cardiac Surgery

Start date: April 2015
Phase: N/A
Study type: Observational

This prospective study will aim to globally assess the coagulopathy induced during cardiac surgery with cardiopulmonary bypass (CPB) in a large pediatric population. The investigators primary objective will be the understanding of CPB-induced coagulopathy based on demographic and surgical characteristics, and coagulation assays. Secondary objective will aim at determining the relationship between coagulation assays, postoperative blood loss, and transfusion requirements. The ultimate goal will be to design an algorithm using point-of-care monitoring that could be used to guide hemostatic therapies in neonates and children undergoing cardiac surgery.To do this, investigators will examine the coagulation in the laboratory based setting.

NCT ID: NCT02347189 Completed - Clinical trials for Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects

Melody PB1016 Surveillance Study

Start date: November 2014
Phase: N/A
Study type: Interventional

Non-randomized, multi-center, prospective surveillance study to investigate and assess the residual risks, and to confirm the currently established safety and performance of the Melody TPV PB1016.

NCT ID: NCT02333097 Completed - Clinical trials for Non Syndromic Congenital Heart

Non Syndromic Congenital Heart Defect and Array-CGH in Prenatal Diagnosis

CAPA
Start date: January 2015
Phase:
Study type: Observational

Comparative genomic hybridization (CGH)-based microarrays are now often used during pregnancy in case of fetal polymalformation in order to assess significant genomic alterations. However, it is not clear whether array-CGH provide a diagnostic utility in case of isolated congenital heart defect. This is the first prospective study aiming at defining the right chromosomal screening when a fetal isolated congenital heart defect is identified by ultrasound.

NCT ID: NCT02326649 Completed - Clinical trials for Congenital Heart Disease

Noninvasive Measurement of CO Using Impedance Cardiography in Patients With CHD

Start date: December 2014
Phase: N/A
Study type: Observational

This study will test the capability of a non-invasive instrument (the PhysioFlow impedance cardiography instrument) to measure cardiac output in patients with congenital heart disease (CHD). This instrument works by placing electrodes on the skin of a patient and measuring electrical impedance through the chest, which is proportional to blood volume and blood flow at any given time. The instrument has been validated in patients with structurally normal hearts, but in the only two studies using it for patients with CHD, it was deemed too inaccurate for clinical use. The manufacturer of the device would require access to data on the patients in order to improve its accuracy, and that has not been feasible thus far. This study would begin by comparing cardiac output based on the PhysioFlow monitor to standard techniques, then after possible changes to the instrument to enhance accuracy, would test the instrument again in the same way.

NCT ID: NCT02320669 Completed - Clinical trials for Congenital Heart Defects

Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

TRICC-2
Start date: November 2014
Phase: Phase 3
Study type: Interventional

This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery. Funding Source - FDA OOPD.

NCT ID: NCT02306057 Completed - Clinical trials for Heart Defects, Congenital

Fluid Balance in Children Undergoing Fontan Surgery

Start date: November 2014
Phase: N/A
Study type: Observational

This project will evaluate fluid balance and edema formation in children with congenital heart disease in need of a surgical procedure, The Fontan procedure. Surgery will make the child end up with a univentricular heart with one-chamber circulation ( Fontan circulation). This project will evaluate if these children has increased micro vascular leakage before surgery due to their congenital heart defect. The project will also investigate if the edema formation seen during cardiac surgery with the use of Cardio-Pulmonary Bypass (CPB) and hypothermia is caused by capillary leakage of plasma protein. The study hypothesis are 1. Edema developed during heart surgery is caused by reduced colloid osmotic pressure gradient through the capillary membrane. 2. The degree of micro vascular leakage in open-heart surgery is related to duration of CPB and hypothermia. 3. Fontan circulation cause peripheral edema related to elevated central venous pressure and is not caused by increased micro vascular leakage of plasma proteins.

NCT ID: NCT02303535 Recruiting - Clinical trials for Congenital Heart Disease (CHD)

National Congenital Heart Disease Audit

Start date: April 2000
Phase: N/A
Study type: Observational

The National Institute of Cardiovascular Outcomes Research (NICOR) collects data and produces analysis to enable hospitals and healthcare improvement bodies to monitor and improve the quality of care and outcomes of cardiovascular patients. The Congenital Heart Disease audit collects data on all cardiac surgery and therapeutic cardiac catheterisations procedures used to treat patients with congenital and acquired heart disease. For acquired heart disease, the audit covers all arrhythmias & cardiomyopathies in patients less than 16 years old only. For congenital heart disease, the audit collects data on both children and adult patients. The audit covers all specialist centers in the UK and Republic of Ireland. The project aims to improve the quality of care for children and adults with congenital heart disease by providing national comparative analysis of procedure specific activity and outcomes of cardiac surgery and therapeutic cardiac catheterisation procedures. The audit also provides quality indicators for the antenatal detection of major congenital heart disease. The current dataset is available from here: http://www.ucl.ac.uk/nicor/audits/congenital/datasets

NCT ID: NCT02287753 Completed - Clinical trials for Congenital Heart Disease

Relationship Between Parameters of VOT Using NIRS and Clinical Outcomes in Pediatric Cardiac Surgery

Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the ability of vascular occlusion test (VOT) during cardiac surgery to predict postoperative outcomes in pediatric patients.