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Heart Defects, Congenital clinical trials

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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: NCT02221921 Not yet recruiting - Clinical trials for Aortic Valve Stenosis

Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI

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

The objective of this study is to evaluate the safety and effectiveness of the MicroPort's Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic stenosis who are considered unsuitable for Surgical Valve Replacement.

NCT ID: NCT01668264 Not yet recruiting - Clinical trials for Congenital Heart Disease

Imaging Assessment of Diastolic Function

Start date: n/a
Phase: Phase 2
Study type: Interventional

Diastolic function is poorly studied in children with congenital heart disease. This is mainly due to the lack of validated techniques. Cardiac MRI offers two advantages compared to echocardiography: 1. accurate measurements of ventricular volumes and mass; 2. tissue characterization. The main advantage of echocardiography is a better temporal resolution which allows the study of short events like early relaxation. Overall there is a lack of studies correlating different echocardiographic and MRI parameters of heart function in pediatric populations with congenital or acquired heart diseases. This study will address specific questions on specific groups of patients that might bring more insight into chamber interaction and cardiac function. This study hypothesizes the following: - Atrial enlargement is a marker of chronic increase in filling pressures and 3D echo might be the best method for follow-up. - Cardiac remodeling associated with chronic loading results in changes in diastolic properties related to changes in cardiac mass and volume. This is related to changes in cardiac mechanics influencing diastolic parameters. Especially the influence on twisting and untwisting will be studied. - Regional myocardial fibrosis and scarring may account for regional systolic and diastolic dysfunction with possible prognostic impact

NCT ID: NCT01278771 Not yet recruiting - Clinical trials for Congenital Heart Disease

Coronary Anomalies in Congenital Heart Disease

CHD
Start date: March 2011
Phase: N/A
Study type: Observational

This is a retrospective study. The investigators shall review the angiography data of 1200 consecutive cardiac catheterizations of children and babies with CHD (Congenital Heart Disease) since 1998 till now. Coronary artery origin and course will be evaluated in relation to the morphologic cardiac anomalies. Coronary artery anomalies will be described and statistical analysis will be performed.