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Congenital Heart Defect clinical trials

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NCT ID: NCT02884973 Not yet recruiting - Clinical trials for Congenital Heart Defect

Prospective Evaluation of Changes in Tissue Oxygen Saturation in Brain and Kidney in Children Admitted to Intensive Care in the Postoperative Period of Cardiac Surgery

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

It is estimated that the incidence of congenital heart disease varies between 0.5 and 1% of live births, 5,000 new cases per year currently in France These are serious diseases that can be life-threatening to more or less short term. The advances in surgical techniques in recent years has improved the prognosis of these patients in the first months of life. The success of surgery is, among other things, conditioned by a support per complex operation, involving a multimodal intensive monitoring, and respiratory and hemodynamic support techniques. These elements of surveillance, NIRS (Near-infrared spectroscopy) allows measurement of non-invasive tissue saturation (rSO2) in cerebral and renal oxygen. The fundamental principle of NIRS based on an estimate of the percentage proportion of cerebral oxy-hemoglobin. A light source is emitted by NIRS and through body tissues to the brain where the light will be absorbed and refracted depending on the tissue composition in oxy-hemoglobin. Refracted light will be analyzed by NIRS which in turn using software will help to determine a percentage of oxyhemoglobin. Normal values of cerebral NIRS are between 50 and 80%.NIRS can be used according to this principle to estimate cerebral tissue oxygenation but also for other tissues such as the kidney. More than the figure, those are changes NIRS compared to a baseline that will alert us to the conditions of tissue oxygenation and allow us to identify hypoxia times. Changes in the value of the NIRS depends on 3 criteria: the tissue blood flow, the percentage of oxyhemoglobin and deoxyhemoglobin percentage.

NCT ID: NCT02860702 Completed - Clinical trials for Congenital Heart Defect

Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology

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

A randomized, blinded, controlled trial to evaluate growth velocity and clinical outcomes in infants with single ventricle physiology fed an exclusive human milk diet prior to, and throughout the post-operative period following, surgical repair. Human milk is defined as expressed human milk or donor milk and its derivatives, human milk-based fortifier and human milk caloric fortifier. The study hypothesis is that infants fed an exclusive human milk diet will have short and long term benefits, with improved wound healing, growth, and neurodevelopmental outcomes while reducing episodes of feeding intolerance and necrotizing enterocolitis (NEC).

NCT ID: NCT02737579 Completed - Clinical trials for Congenital Heart Defect

XFM: (X-ray Fused With MRI) Guided Cardiac Catheterization

Start date: July 23, 2013
Phase: N/A
Study type: Interventional

This study will evaluate the use of x-ray fused with MR images as an imaging tool to help guide catheter tools during diagnostic and therapeutic cardiac catheterization procedures.

NCT ID: NCT02658266 Recruiting - Clinical trials for Congenital Heart Defect

Effect of Resistance Training in Adults With Complex Congenital Heart Disease

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

Adults with complex congenital heart disease have impaired muscle function compared both to health controls and patients with lesions classified as simple. There is only one study assessing the effects of resistance training in patients palliated with Fontan procedure. The hypotheses of the present study is that home based resistance training will improve muscle function in adults with different complex congenital hear diseases.

NCT ID: NCT02493634 Completed - Clinical trials for Congenital Heart Defect

Post-market Clinical Follow-up Study With Magnetic Resonance Imaging Conditional Guide Wire

MRWIREPMCF
Start date: August 2015
Phase: N/A
Study type: Interventional

This is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety and performance of magnetic resonance imaging conditional guide wire and the acceptability of identified risks in the clinical evaluation and to detect emerging risks on the basis of factorial evidence.The procedure will be done in patients with a clinical indication for cardiac magnetic resonance and conventional catheterisation.

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: NCT02258724 Recruiting - Clinical trials for Congenital Heart Disease

Swiss National Registry of Grown up Congenital Heart Disease Patients

GUCH
Start date: September 2013
Phase:
Study type: Observational [Patient Registry]

Due to successes in the last decades in pediatric heart surgery and cardiology, 90-95% of the children with congenital heart disease reach adult age.This results in an increasing number of adults or "grown-ups" with congenital heart disease (ACHD or GUCH patients) that require special health care organization and training programmes. Long term complications of these GUCH patients and optimum treatment strategies are still poorly known. The aim of this registry is to collect quantitative and qualitative data regarding GUCH patients treated in specialised centres in Switzerland.

NCT ID: NCT02240147 Completed - Clinical trials for Congenital Heart Defect

Start-to-Sport - Home-based Exercise for Adolescents and Adults With Congenital Heart Disease

S2S-ACHD
Start date: January 1, 2015
Phase: N/A
Study type: Interventional

Almost 1% of all baby's is born with a heart defect (CHD) and most of them survive. Even though outcomes are good, they need lifelong follow-up because of a higher risk for cardiovascular diseases. Studies have shown that patients with CHD are not active enough and that a substantial amount of patients is overweight. Hence preventive strategies and education should not only focus on the heart problem, but also on a healthy lifestyle including physical activity. Recently a new guideline introduced exercise prescription based on the absence/presence of certain key elements. However, a number of important questions remain that preclude implementation in clinical practice. Therefore a 'Start-to-Sport' program for adults with CHD, based on this new guideline, will be investigated. This study is a randomized controlled trial that investigates the effects of the program on daily physical activity, exercise capacity, quality of life and exercise self-efficacy both in short (12 weeks) and long (52 weeks) term, along with possible mechanisms for the training effects by using a new exercise-testing protocol that looks simultaneously to all body parts that are involved during exercise. Ultimately, our findings will result in the implementation of the guideline in clinical practice.

NCT ID: NCT01678274 Active, not recruiting - Hypertension Clinical Trials

Prospective Characterization of the Heart, Aorta and Blood Pressure in Turner Syndrome. Association With Aortic Dissection.

TSCORII
Start date: December 2013
Phase: N/A
Study type: Observational

Turner syndrome is a congenital complete or partial lack one of the female sex chromosomes affecting 1 of 2000 live born girls. The syndrome is characterized by an increased prevalence of ischemic heart disease, aortic dilation and dissection, hypertension, stroke and autoimmune diseases in general. Our study aim is: - Using MRI to further characterize and find risk factors leading to aortic dilation. - Using MRI to assess the degree of aortic distensibility. - Using Computed tomography x-ray scanning of the heart and coronary arteries to characterize the prevalence and degree of ischemic heart disease and coronary anomalies. - Using pressure sensitive ultrasound (applanation tonometry) to assess the degree of aortic stiffness when compared to controls using end points as Pulse Wave Velocity, Augmentation Index and Central Pulse Pressure.

NCT ID: NCT01330433 Completed - Hemorrhage Clinical Trials

Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

Start date: August 2011
Phase: Phase 2
Study type: Interventional

This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate the effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene glycol on the formation of mediastinal and pericardial adhesions in children undergoing staged surgical reconstruction (potential procedures include: Blalock-Taussig Type Operation, Classical Glenn Procedure, Bidirectional Glenn Procedure, Norwood). Additionally, bleeding will be evaluated by drainage post-operatively through surgical site drainage output.