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Heart Defects, Congenital clinical trials

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NCT ID: NCT06034392 Enrolling by invitation - Pediatrics Clinical Trials

CHAMP App Cardiac Study and Repository

CHAMP
Start date: August 25, 2023
Phase:
Study type: Observational [Patient Registry]

This is a multi-site research study with an optional research repository that will consist of clinically derived data and photographic or video images of patients in the home setting with complex health conditions to evaluate the safety and efficacy of the CHAMP® software platform, with data and photographic or video images input and/or uploaded by the parent or other legally authorized representative (LAR) of patients with complex congenital heart disease as a target population.

NCT ID: NCT05979870 Enrolling by invitation - Clinical trials for Magnetic Resonance Imaging

Artificial Intelligence in New Cardiac MR Markers for Congenital Heart Disease

AI-CMR
Start date: October 1, 2022
Phase:
Study type: Observational

The goal of this study is to investigate children with aortic and pulmonary valve disease treated or untreated longitudinally. Established CMR measures with additional newly developped, promising, highly refined and clinically applicable quantitative imaging biomarkers, will be utilized as compared to the conventional CMR estimates. The main question[s] it aims to answer are: - [question 1]To evaluate risk stratification for surgery and intervention of the aortic- and pulmonary valve - [question 2]Investigate the cardiac and vascular hemodynamic and morphological changes before and after interventional or surgical treatment of the aortic- and pulmonary valve at short and long term. Participants will undergo cardiac MRI before and after interventional or surgical treatment of the aortic or pulmonary valve Researchers will compare MRI data to an age matched control group established at the department in another study.

NCT ID: NCT05975658 Enrolling by invitation - Pediatrics Clinical Trials

WIReD: Wireless Interstage Remote Device Study

WIReD
Start date: September 30, 2023
Phase:
Study type: Observational

A mixed-methods study will be used to evaluate the use of standard of care periodic pulse oximetry by parents/LAR and the feasibility of the collection of physiologic data related to the use of the Pediarity System. This system includes the Gabi Band and software platform (Gabi Analytics).

NCT ID: NCT05454501 Enrolling by invitation - Clinical trials for Congenital Heart Disease

The Effects of Telerehabilitation and Exercise Training in Pediatric Arrhythmia Patients With Pacemakers

Start date: May 31, 2022
Phase: N/A
Study type: Interventional

There is no study evaluating online exercise training and results in children with pacemakers. This study investigates the effects of group exercise training performed via computer online videoconferencing in pediatric arrhythmia patients with pacemakers. Pediatric arrhythmia patients aged 6-18 years with a pacemaker, stable clinically, and living with at least one parent or caregiver who can support them at home will be included in the study. Eligible patients will be randomly divided into two groups. After the face-to-face evaluation session, those in the intervention group will receive real-time online exercise training for 30 minutes, three days a week, with a peer group of 5-6 people for eight weeks. Physical activity will be monitored for seven days before starting the exercise and seven days after the training is completed. After the first face-to-face evaluation session, patients in the control group and their families will receive a 1-hour disease- and exercise-specific patient education program. Information brochures containing physical activity and exercise recommendations will be given. They will be followed up with weekly phone calls throughout the study period.

NCT ID: NCT05270356 Enrolling by invitation - Clinical trials for Adult Congenital Heart Disease

MINDS Imaging Ancillary Study

MINDS
Start date: May 27, 2021
Phase:
Study type: Observational

This study is an ancillary study to the NHLBI-funded Pediatric Heart Network (PHN) "Multi-Institutional Neurocognitive Discovery Study" (MINDS) in Adult Congenital Heart Disease (ACHD). The MINDS-ACHD" study will recruit 500 complex CHD patients between18-30 years old. The investigators propose to quantitate multi-modal neuroimaging biomarkers (brain injury, structure and physiology) which are not only important components of brain and cognitive reserve but can be predictive of neurocognitive decline and early onset of dementia in the aging non-CHD population.

NCT ID: NCT05195788 Enrolling by invitation - Clinical trials for Congenital Heart Disease

Cardiac Rehabilitation in Congenital Heart Disease: Effects on Brain and Cognitive Functions

CongeNIRS
Start date: February 7, 2022
Phase: N/A
Study type: Interventional

The proposed trial is designed to evaluate the effect of an individualised cardiac rehabilitation program, consisting of aerobic and muscle strengthening exercises, on brain activity and cognitive functions in adults with congenital heart disease

NCT ID: NCT05101746 Enrolling by invitation - Clinical trials for Congenital Heart Disease

Nitric Oxide Effect on Brain and Kidney in Pediatric Patients Undergoing Cardiopulmonary Bypass

Start date: April 25, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The goals of this study are: 1. To evaluate the neuroprotective effect of nitric oxide by measuring glial fibrillary acid protein (GFAP) before and after surgery. GFAP will be analyzed via an enzyme-linked immunosorbent assay (ELISA) kit. Patients will also be monitored post-operatively for delirium in the intensive care unit (ICU). 2. To evaluate the renal protective effect of nitric oxide by measuring neutrophil gelatinase-associated lipocalin (NGAL) before and after surgery. NGAL will also be analyzed via an ELISA kit. Patient creatinine will be monitored post-operatively. 3. To evaluate effect of nitric oxide on other ICU outcomes (invasive mechanical ventilation, days to extubation, ICU and hospital length of stay, and blood product administration).

NCT ID: NCT04866537 Enrolling by invitation - Clinical trials for Heart Defects, Congenital

Evaluation of the Diagnostic Performance of Specialized Fetal Cardiac Ultrasound in the CPDPN - Arc Alpin Network

Qualicard
Start date: October 30, 2020
Phase:
Study type: Observational

To evaluate the diagnostic performance of antenatal echocardiography with regard to the main diagnosis of heart disease made by cardio-pediatricians at the couple-child hospital in Grenoble according to the ACC-CHD classification, in pregnant women who have had a fetal heart ultrasound between 2015 and 2019. *ACC-CHD : Anatomic and Clinical Classification of Congenital Heart Defects

NCT ID: NCT04734782 Enrolling by invitation - Clinical trials for Respiratory Syncytial Virus, Congenital Heart Disease

Assess the Correlation With Severe Respiratory Syncytial Virus Disease in the First 6 Months in Children With Congenital Heart Disease and Maternal Ac-AntiVSR Titers During Pregnancy

(VSRyCC)
Start date: February 15, 2021
Phase:
Study type: Observational

Passive transplacental immunity against the respiratory syncytial virus (RSV) appears to mediate infant protection during the first 6 months of life (1). Observations of environmental exposure in pregnant women during an RSV epidemic could influence these children's susceptibility to infection by offering levels of antibodies that are transferred to the fetus. However, there is no prospective study in the population at risk such as children with congenital heart disease, as well as the effective levels of anti-RSV immunoglobulin G (IgG) as protective biomarkers for RSV infection after delivery (2) Justification The most serious evolution of the clinical disease of acute RSV bronchiolitis in children under 6 months of age is related to lower exposure of the pregnant woman to the RSV epidemic. With maternal immunization through natural exposure, it is logical to relate protection to children for severe RSV disease. However, it is not proven (3). 1. - Nandapalan N, Taylor CE, Greenwell J, et al. Seasonal variations in maternal serum and mammary immunity to RS virus. J Med Virol. 1986;20(1):79-87. doi:10.1002/jmv.1890200110 2. - Stensballe LG, Ravn H, Kristensen K, Meakins T, Aaby P, Simoes EA. Seasonal variation of maternally derived respiratory syncytial virus antibodies and association with infant hospitalizations for respiratory syncytial virus. J Pediatr. 2009;154(2):296-298. doi:10.1016/j.jpeds.2008.07.053 3. - Ramos-Fernández JM, et al. Does exposure of pregnant women to epidemic respiratory syncytial virus affect the severity of bronchiolitis? Enferm Infec Microbiol Clin. 2017. https://doi.org/10.1016/j.eimc.2018.07.002)

NCT ID: NCT04548804 Enrolling by invitation - Cardiac Arrest Clinical Trials

Better Mechanistic Understanding of and Risk Stratification for Ventricular Tachyarrhythmias Through ECGI

BREACH-ECGI
Start date: June 10, 2020
Phase: N/A
Study type: Interventional

This study aims to evaluate the electrophysiological properties of the heart conduction system in patients with (increased risk of) ventricular tachyarrhythmias (VTA) and sudden cardiac arrest, and in a control cohort. The electrophysiological properties will be measured with the relatively new technique ECG-Imaging (ECGI). Moreover, clinical data of subjects will be gathered. By combining the data from the data gathering and the results of ECGI, the investigators hope to increase mechanistic understanding of and risk stratification for VTAs. The investigators aim to be able to identify patients at risk of an arrhythmic event, and aim for better treatment strategies in the future.