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Heart Defects, Congenital clinical trials

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NCT ID: NCT03207295 Recruiting - Clinical trials for Congenital Heart Disease

Impact of Nesiritide on Early Postoperative Recovery After Total Cavo-Pulmonary Connection Surgery in Children

Start date: July 5, 2017
Phase: N/A
Study type: Interventional

Nesiritide, a recombinant human B-type natriuretic peptide, has favorable effects on patient symptoms, hemodynamics, and the neurohumoral profile in adults with decompensated congestive heart failure and in those recovering from cardiac surgery involving cardiopulmonary bypass. Investigators seek to determine whether nesiritide would improve the early postoperative course after total cavo-pulmonary connection surgery in children.

NCT ID: NCT03152773 Recruiting - Clinical trials for Congenital Heart Disease

Heart Catheterization Using Magnetic Resonance Imaging (MRI) Fluoroscopy and Passive Guidewires

Start date: August 2, 2017
Phase: N/A
Study type: Interventional

Background: A heart catheterization is a diagnostic heart procedure used to measure pressures and take pictures of the blood flow through the heart chambers. Magnetic resonance imaging (MRI) fluoroscopy shows continuous pictures of the heart chambers that doctors can watch while they work. Researchers want to test this procedure with catheterization tools routinely used in x-ray catheterization called guidewires. Guidewires will help move the heart catheter through the different heart chambers. Guidewires are usually considered unsafe during MRI because MRI can cause a guidewire to heat while inside the blood vessels and heart. Researchers are testing special low energy MRI settings that allow certain guidewires to be used during MRI catheterization without heating. Using these guidewires during MRI may help to decrease the amount of time you are in the MRI scanner, and the overall time the MRI catheterization procedure takes. Objectives: To test if certain MRI settings make it safe to use a guidewire during MRI fluoroscopy. Eligibility: Adults 18 and older whose doctors have recommended right heart catheterization. Design: Researchers will screen participants by reviewing their lab results and questionnaire answers. Participants may give 4 blood samples. Participants will be sedated. They will have a tube (catheter) placed in the groin, arm, or neck if they don t already have one. Patches on the skin will monitor heart rhythm. Special antennas, covered in pads, will be placed against the body. Participants will lie flat on a table that slides in and out of the MRI scanner as it makes pictures. Participants will get earplugs for the loud knocking noise. They can talk on an intercom. They will be inside the scanner for up to 2 hours. They can ask to stop at any time. During a heart catheterization, catheters will be inserted through the tubes already in place. The catheters are guided by MRI fluoroscopy into the chambers of the heart and vessels. The guidewire will help position the catheter.

NCT ID: NCT03147014 Recruiting - Clinical trials for Hypoplastic Left Heart Syndrome

Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease

Start date: January 1, 2016
Phase: N/A
Study type: Interventional

Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease

NCT ID: NCT03119155 Recruiting - Clinical trials for Congenital Heart Disease

Improvement on Diagnosis of Fetal Congenital Heart Disease Based on Multi-center Collaboration in China

Start date: December 1, 2018
Phase:
Study type: Observational [Patient Registry]

The objective of this study is to improve the diagnosis level of fetal congenital heart disease by the multi-center collaboration in China.

NCT ID: NCT02996630 Recruiting - Clinical trials for Congenital Heart Disease

Assessing Neurodevelopment in Congenital Heart Disease.

NEUROHEART
Start date: May 2013
Phase: N/A
Study type: Interventional

Congenital heart disease (CHD) is the most prevalent congenital malformation affecting 1 in 100 newborns per year. Children with CHD are a known risk population for brain injury, with neurodevelopmental alterations shown over time in up to 50% of cases. No adequate description exists of the type of neurocognitive anomalies or risk factors associated with CHD, and consequently no prognostic markers that may allow identification of high-risk cases are available.

NCT ID: NCT02995577 Recruiting - Clinical trials for Single Ventricle Physiology

Biomarkers for Feeding Intolerance in Infants With Complex Congenital Heart Defects Undergoing Single Ventricle Staged Palliation

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

The purpose of this study is to investigates serum and stool biomarkers as predictors for post-operative feeding intolerance in infant patients with complex congenital heart defects who undergo single ventricle staged palliation surgery.

NCT ID: NCT02970071 Recruiting - Clinical trials for Congenital Heart Disease

The Application Value of STIC in the Diagnosis of Fetal Complex Congenital Heart Disease

STIC
Start date: April 25, 2017
Phase:
Study type: Observational

The objective of this study is to use of STIC technology to assist the traditional echocardiography to diagnose the fetal congenital heart disease accurately and then to provide a basis for prenatal counseling.

NCT ID: NCT02928133 Recruiting - Atrial Fibrillation Clinical Trials

NOACs for Atrial Tachyarrhythmias in Congenital Heart Disease

NOTE
Start date: April 2014
Phase: N/A
Study type: Observational [Patient Registry]

Rationale: Adult patients with congenital heart disease (CHD) with atrial tachyarrhythmias need to be anticoagulated. It is not known whether non-vitamin K antagonist oral anticoagulants (NOAC) in this patient group are efficient and safe. Aim: The purpose of the NOTE registry is to evaluate the efficacy and safety of NOACs for thromboembolic prevention in atrial tachyarrhythmias in adult patients with congenital heart disease (CHD). Methods: In this multicenter prospective registry adult CHD patients with atrial tachyarrhythmias on NOACs (switch from VKA or new on anticoagulants) will be followed for a minimum of two years. Primary efficacy endpoints are defined as thromboembolism, i.e. the composite of ischemic stroke, systemic and pulmonary embolism and intracardiac thrombosis, and as the composite of stroke and systemic embolism. Primary safety endpoint is defined as major bleeding according to the ISTH criteria. Secondary endpoints include each thromboembolic or bleeding event analysed separately, all-cause mortality, therapy adherence, quality of life, risk assessment of stroke and evaluation of natural history of atrial tachyarrhythmia in adult CHD patients. Primary endpoint assessment will be performed with a per protocol analysis, and demonstrated as Kaplan Meyer estimates of event free survival and event rates per year.

NCT ID: NCT02923440 Recruiting - Clinical trials for Congenital Heart Defects

Creation of a French South-Eastern Database and DNA-bank of Congenital Heart Disease to Explore the Genetic Pathways

SEA-HD
Start date: January 17, 2017
Phase: N/A
Study type: Interventional

Congenital heart defects are seen in 0,8% of life births. In France this means more than 5000 newborns per year. The south-east region of France is particularly affected as a result of a higher birth rate and consanguinity, when compared to other regions. The majority of congenital heart diseases remain unexplained. Genetic causes are indisputable but remain poorly understood. Genetic research needs the availability of a large-scale DNA collection, guided by a robust phenotypic classification. Such a DNA-bank has been created in Paris (CARREG DNA bank, created by the M3C reference centre for congenital heart diseases). Such a bank is currently unavailable in south-east France. To transport biological specimens from Marseille to Paris would be very expensive. In addition, the whole infrastructure required for correct diagnosis and classification of the congenital heart diseases, for sampling, for storage of the samples and genetic analysis, does exist in our AP-HM hospital and in our AMU research unit. For those reasons it is highly preferable to elaborate such a database and DNA-bank locally. The acronym SEA-HD (South-EAst-Heart-Diseases) would be used to name this DNA-bank

NCT ID: NCT02914392 Recruiting - Clinical trials for Congenital Heart Disease

Study on the Relationship Between Maternal Exposure to Environmental Factors and Fetal Congenital Heart Disease

Start date: May 18, 2017
Phase: N/A
Study type: Observational

The objective of this study is to research the relationship between maternal exposure to environmental factors and fetal congenital heart disease in a community-based case-control study.