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Congenital Heart Disease clinical trials

View clinical trials related to Congenital Heart Disease.

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NCT ID: NCT03837574 Recruiting - Clinical trials for Congenital Heart Disease

French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator

DAI-T4F
Start date: December 1, 2010
Phase:
Study type: Observational [Patient Registry]

National french registry of patients with tetralogy of Fallot and implantable cardioverter defibrillator.

NCT ID: NCT03833843 Completed - Clinical trials for Congenital Heart Disease

Sudden Cardiac Death in Systemic Right Ventricle

STARSII
Start date: September 1, 2018
Phase:
Study type: Observational

In complete transposition of the great arteries (TGA) with previous atrial switch repair, and congenitally corrected transposition of the great arteries (ccTGA), the morphological right ventricle and its tricuspid valve continue to support the systemic circulation. This results in late complications including including sudden death. This retrospective multicentric study aims to evaluate the prevalence of SCD in a contemporary population of patients with a systemic RV and identify specific risk factors for SCD and hemodynamically significant ventricular arrhythmia This registry records demographics, clinical, imaging data, electrophysiological and laboratory of patients with a sRV and a transposition of the great arteries Primary end points are defined by sudden cardiac death, near-miss sudden death, as well as sustained VT requiring defibrillation.

NCT ID: NCT03786497 Not yet recruiting - Clinical trials for Congenital Heart Disease

Protecting Brains and Saving Futures - the PBSF Protocol

PBSF
Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

Background: Multiple neonatal disorders are associated with risks of neurological injury. Thus, management of these infants should involve a coordinated approach to permit early diagnosis with improved clinical care. Such initiative involves the use of standardized protocols, continuous and specialized brain monitoring with electroencephalography (EEG), amplitude integrated EEG (aEEG) and Near Infrared Spectroscopy (NIRS), neuroimaging and training. Brazil is a very large country with disparities in health care assessment; some neonatal intensive care units (NICUs) are not well structured and trained to provide adequate neurocritical care. However, the development and implementation of these neurocritical care units requires high expertise and significant investment of time, manpower and equipment. In order to reduce the existing gap, a unique advanced telemedicine model of neurocritical care called Protecting Brains and Saving Futures (PBSF) protocol was developed and implemented in some Brazilian NICUs. Methods: A prospective observational cohort study will be conducted in 20 Brazilian NICUs that have adopted the PBSF protocol. All infants receiving the protocol during January 2021 to December 2023 will be eligible. Ethical approval will be obtained from the participating institutions. The primary objective is to describe the use of the PBSF protocol and clinical outcomes, by center and over a 3 years period. The use of the PBSF protocol will be measured by quantification of neuromonitoring, neuroimaging exams and sub-specialties consultation. Clinical outcomes of interest after the protocol implementation are length of hospital stay, detection of EEG seizures during hospitalization, use of anticonvulsants, inotropes, and fluid resuscitation, death before hospital discharge, and referral of patients to high-risk infant follow-up. These data will be also compared between infants with primarily neurologic and primarily clinical diagnosis. Discussion: The implementation of the PBSF protocol may provide adequate remote neurocritical care in high-risk infants with optimization of clinical management and improved outcomes. Data from this large, prospective, multicenter study are essential to determine whether neonatal neurocritical units can improve outcomes. Finally, it may offer the necessary framework for larger scale implementation and help in the development of studies of remote neuromonitoring.

NCT ID: NCT03775954 Recruiting - Clinical trials for Congenital Heart Disease

Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise

Start date: July 1, 2018
Phase:
Study type: Observational

Each year world-wide, 2.5 million fetuses die unexpectedly in the last half of pregnancy, 25,000 in the United States, making fetal demise ten-times more common than Sudden Infant Death Syndrome. This study will apply a novel type of non-invasive monitoring, called fetal magnetocardiography (fMCG) used thus far to successfully evaluate fetal arrhythmias, in order to discover potential hidden electrophysiologic abnormalities that could lead to fetal demise in five high-risk pregnancy conditions associated with fetal demise.

NCT ID: NCT03757312 Completed - Clinical trials for Congenital Heart Disease

A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass

Start date: April 24, 2019
Phase: N/A
Study type: Interventional

The purpose of the proposed study is to evaluate the incidence of subtle increases in intracranial pressure (ICP) following cardiopulmonary bypass (CPB) using optic nerve sheath diameter (ONSD), measured by non-invasive ultrasound. As direct measurements of ICP are not feasible following CPB, ONSD will be used as a correlate of ICP. ONSD has been shown to be effective in the ICU and emergency room setting for detecting increased ICP and is an accepted standard for such measurements. The primary hypothesis is that changes in ICP occur following CPB without clinically appreciable signs and symptoms. These changes in ICP will be reflected by changes in ONSD. If there is a significant incidence of sub-clinical cerebral edema and increased ICP postoperatively, these findings may impact postoperative hemodynamic and ventilation goals and techniques.

NCT ID: NCT03678909 Completed - Clinical trials for Congenital Heart Disease

Cardiac Biomarkers in Patients With Single Ventricle Physiology

Start date: March 1, 2018
Phase:
Study type: Observational

All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and Troponin level before the surgical procedure, on arrival to the cardiac intensive care unit after their surgical procedure, every 6 hours during the first 24 hours of the post-operative period, followed by daily levels for the first week, and then weekly during patient's regular laboratory work up schedule. These cardiac biomarkers are linked to demographic, hemodynamic, respiratory, pharmacological data available via Sickbay.

NCT ID: NCT03677232 Completed - Quality of Life Clinical Trials

The Living Experience of Hong Kong Chinese Adolescents With CHD.

Start date: August 11, 2017
Phase:
Study type: Observational [Patient Registry]

This study aims to explore the impacts of CHD and its limitations on adolescents and the living experience of adolescents living with CHD. Hong Kong Chinese adolescents with CHD are having reduced psychological well-being and quality of life than their healthy counterparts. Qualitative study is therefore needed to explore how CHD may impact on the adolescents' psychological well-being and quality of life.

NCT ID: NCT03667703 Completed - Infection Clinical Trials

Stress Ulcer Prophylaxis Versus Placebo in Critically Ill Infants With Congenital Heart Disease

SUPPRESS-CHD
Start date: March 10, 2019
Phase: Phase 4
Study type: Interventional

Infants with congenital heart disease often require an intervention during their first year of life. Infants are generally admitted to a cardiac intensive care unit and are routinely prescribed stress ulcer prophylaxis to decrease acid release from the stomach to prevent stress ulcer formation. However, these medicines may not be safe and could put infants at increased risk for hospital-acquired infections, necrotizing enterocolitis and alteration to the infant's microbiome. The investigators plan to assess the feasibility of conducting a prospective, blinded randomized control trial to determine the safety of withholding stress ulcer prophylaxis in critically ill infants with congenital heart disease. In addition, the investigators plan to examine the changes to the infant's microbiome through oral, gastric and stool samples and compare hospital-acquired infections.

NCT ID: NCT03657823 Recruiting - Clinical trials for Congenital Heart Disease

Fetal Growth and Pregnancy Complications Among Women With Heart Disease

PreCor
Start date: May 15, 2018
Phase:
Study type: Observational [Patient Registry]

An increasing proportion of women with heart disease now go through pregnancy and childbirth. More knowledge about the risk of complications and adverse outcomes for the mother and the baby is needed to guide clinical care in this diverse patient group. The purpose of this study is to, in a cohort of pregnant women with heart disease; - determine fetal growth, and risk of fetal growth restriction and preterm birth - determine whether maternal blood biomarkers are associated with development of preeclampsia, the time of delivery and maternal and perinatal adverse outcomes - determine the risk of hypertensive pregnancy complications The expected outcome of the project is to increase the knowledge of optimal diagnosis and treatment of women with heart disease that go through pregnancy to be able to improve clinical care and the outcomes for mother and baby.

NCT ID: NCT03629574 Not yet recruiting - Clinical trials for Congenital Heart Disease

Mechanical Ventilation During Cardiopulmonary Bypass

VENICE
Start date: August 20, 2018
Phase: N/A
Study type: Interventional

The study is about a protocol of protective mechanical ventilation during cardiopulmonary bypass used during cardiosurgery for the correction of congenital heart diseases, to evaluate what's the best for the lungs