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Heart Defects, Congenital clinical trials

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NCT ID: NCT00883285 Completed - Clinical trials for Aortic Valve Disease

Incidence and Severity of Silent and Apparent Cerebral Embolism After Conventional and Minimal-invasive Transfemoral Aortic Valve Replacement

Start date: April 2009
Phase: N/A
Study type: Observational

The purpose of this study is to compare the incidence of silent and apparent cerebral embolism between conventional and minimal-invasive transfemoral aortic valve repair.

NCT ID: NCT00881686 Completed - Clinical trials for Heart Defects, Congenital

Myocardial Protection With Adenosine Preconditioning

Start date: June 2008
Phase: Phase 1/Phase 2
Study type: Interventional

Adenosine has been proved to be an important mediator of myocardial protection induced by ischemic preconditioning. The hypothesis of this study is that adenosine preconditioning can provide additional myocardial protection in the setting of pediatric open heart surgery with cardioplegia and cardiopulmonary bypass.

NCT ID: NCT00868101 Completed - Clinical trials for Congenital Heart Disease

The Effect of Remote Ischemic Preconditioning Applied in Children the Day Before Open Heart Surgery

Start date: January 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The study research is to analyse brief episodes of limb ischemia applied to children the day before open heart surgery as protection from myocardial injury induced by extracorporeal circulation.

NCT ID: NCT00860327 Terminated - Tetralogy of Fallot Clinical Trials

Examining Developmental Changes in Heart Contractions of Children With Congenital Heart Defects

Start date: December 2007
Phase: N/A
Study type: Observational

Children who are born with heart defects undergo surgery when they are infants to correct the defects. However, many treatments that are used in pediatric heart patients were originally developed for adults and may not be the best option for children. This study will analyze tissue samples from newborns and infants undergoing surgery for heart defects to learn more about how a child's heart develops during the first year of life. This information may help to identify possible treatments geared specifically for the pediatric heart patient.

NCT ID: NCT00850720 Terminated - Clinical trials for Congenital Heart Disease

Study of Possible Brain Hormone Problems After Open Heart Surgery in Infants

Start date: March 2009
Phase: N/A
Study type: Observational

The goal of this study is to evaluate specific hormone levels in children undergoing heart surgery in order to identify patterns associated with any unstable vital signs. The data collected will provide preliminary answers to the question "Are hormone values a determining factor for drug administration and dosing levels?" and help establish the benefits of routine steroid and hormone administration. Sixty subjects will be enrolled. Blood samples will be drawn before the surgery,and again nine hours after surgery for analysis. Other patient data such as medications, vital signs, routine lab values and treatments will also be analyzed. As our current standard of care includes routine doses of steroids, we believe this study will increase our general knowledge and improve the care of these critically ill children. The study will also provide the foundation needed for grant support from the American Heart Association, allowing for future larger scale studies.

NCT ID: NCT00848250 Completed - Clinical trials for Congenital Heart Disease

Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children

Start date: September 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether ACE inhibitors alter the fibrinolytic, inflammatory, and hemodynamic response to cardiopulmonary bypass in infants and children with congenital heart disease.

NCT ID: NCT00833703 Completed - Clinical trials for Heart Defects, Congenital

Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation

CLARINET LT
Start date: January 2009
Phase: Phase 3
Study type: Interventional

This study is the extension of the CLARINET study [NCT00396877 -EFC5314] in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt. The primary objective was to assess the safety up to 18 months of age of the extended use of Clopidogrel 0.2 mg/kg/day in patients for whom the shunt was still in place at one year of age. The secondary objective was to assess the efficacy on the occurrence of shunt thrombosis requiring intervention or any death.

NCT ID: NCT00807274 Withdrawn - Kidney Failure Clinical Trials

Renal Function in Adults With Congenital Heart Disease.

Start date: September 2008
Phase: N/A
Study type: Observational

Impaired kidney function is associated with a poor outcome in patients with heart failure but it is not known of this is the case for patients who have been born with their heart condition (congenital heart disease). This study aims to investigate how frequently patients with congenital heart disease have kidney disease and whither this does have an impact on their outcome. The hypothesis is that kidney dysfunction will be common in these patients and may have an impact on long-term health and life-expectancy.

NCT ID: NCT00772135 Recruiting - Clinical trials for Congenital Heart Disease

Reversibility by Sildenafil of Exercise-Induced Abnormal Right Ventricular Pressure Response in ASD and VSD-Operated Patients

Start date: September 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether oral sildenafil citrate reduces the abnormal right ventricular pressure response during exercise in adolescent and adult patients with specific types of congenital heart defects.

NCT ID: NCT00770705 Withdrawn - Clinical trials for Congenital Heart Disease

Parenteral Phenoxybenzamine During Congenital Heart Disease Surgery

Start date: October 2008
Phase: Phase 2
Study type: Interventional

Phenoxybenzamine, an irreversible alpha-adrenergic blocker, may prove beneficial to infants and children with congenital heart disease undergoing open cardiac repair, due to a theoretic benefits of a uniform and smooth reduction in systemic vascular resistance in the perioperative period. Vasodilation allows for low pressure, high flow systemic perfusion while on cardiopulmonary bypass. Support for the use of phenoxybenzamine in humans has been documented in several studies involving the perioperative management of both adults and children requiring cardiopulmonary bypass, and in management of patients with pheochromocytoma. 1-7 Phenoxybenzamine has been associated with more uniform body cooling and rewarming, and improved tissue perfusion during bypass.8 It is also known to increase cardiac output, stroke volume, and renal blood flow when given intravenously. 9 Specifically in pediatric open heart surgery, the combined use of phenoxybenzamine and dopamine provided a stable hemodynamic condition without a high total peripheral vascular resistance and stimulated postoperative diuresis. 9 Afterload reduction with parenteral phenoxybenzamine in neonates undergoing the Norwood procedure for hypoplastic left heart syndrome is associated with improved systemic oxygen delivery and stabilization of systemic vascular resistance.10 Furthermore, a strategy of reducing afterload with phenoxybenzamine and stabilizing the pulmonary to systemic flow ratio in this select population of patients has also been shown to improve operative survival. 11 We hypothesize that phenoxybenzamine will reduce afterload on the systemic ventricle in our selected patient population, thereby improving ventricular performance and decreasing the risks of pulmonary to systemic flow imbalance associated with current short-acting vasodilator therapy. We will plan to evaluate both physiologic variables as well as surgical outcomes in the selected study population.