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Heart Defects, Congenital clinical trials

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NCT ID: NCT06126484 Recruiting - Clinical trials for Transcatheter Neonatal Cardiac Interventions

Neonatal Transcatheter Cardiac Interventions at Sohag University Hospital

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

This study is performed to assess the safety, efficacy and outcome of transcatheter cardiac interventions in neonates with critical congenital heart disease at Sohag University Hospital

NCT ID: NCT06126367 Recruiting - Atherosclerosis Clinical Trials

Assessment of Lipoprotein(a) and Endogenous Fibrinolysis in Atherosclerotic Cardiovascular Disease/Aortic Valve Disease

ALFA
Start date: October 20, 2023
Phase:
Study type: Observational

Prior studies have shown that impaired endogenous fibrinolysis is a novel, independent cardiovascular risk factor in patients with myocardial infarction and there is currently no known chronic treatment to enhance endogenous fibrinolysis. To date, no therapies have been able to sufficiently reduce Lp(a) and therefore it was considered to be a non-modifiable cardiovascular risk factor. New data, however, has shown that PCSK9 inhibitors and inclisiran (medication that you have been deemed eligible for in order to help further reduce your cholesterol levels) to reduce Lp(a) levels by approximately 20-25%. The aim of this study to is to assess: 1. if there is an association between raised Lp(a) level in blood and the effectiveness of endogenous fibrinolysis (lysis time). 2. whether lowering Lp(a) with PCSK9i or inclisiran can enhance endogenous fibrinolysis

NCT ID: NCT06124443 Not yet recruiting - Clinical trials for Congenital Heart Defects

Congenital Heart Defects

Start date: December 1, 2024
Phase:
Study type: Observational

Describe the relationship between maternal diabetes and congenital heart defects in infants born to diabetic mothers referred to NICU unit & Outpatient clinics of Assiut University Childeren's hospital.We will compare between 2 groups. Cases will represent infants of diabetic mothers & Conteols will represent infants of non-diabetic mothers.

NCT ID: NCT06110689 Recruiting - Pectus Excavatum Clinical Trials

Capturing Physiologic Autonomic Data From Clinically Indicated Magnetic Resonance Imaging Scans in Children

CMRI
Start date: October 3, 2023
Phase:
Study type: Observational

The Fontan Procedure is a palliative surgical procedure used in pediatric patients with one functional ventricle. The procedure, a series of stepwise operations that alter cardiorespiratory physiology, separate the systemic and pulmonary circulations to create Fontan physiology, where the systemic venous blood flows passively and without ventricular thrust into the pulmonary circulation. The hallmark of the Fontan circulation is a sustained, abnormally elevated central venous pressure combined with decreased cardiac output, especially during periods of increased demands. Results of several studies in Fontan patients have shown reduced parasympathetic and sympathetic activity compared to controls. In children with congenital heart disease, a differential diagnosis of autonomic dysfunction may be part of their pathophysiology, a compensatory mechanism, a consequence of surgical procedures or a combination of these. In children, measurement of ANS function is equally important. Children with single ventricle physiology (and other cardiac conditions) have routine surveillance and cardiac magnetic resonance (CMR) imaging to monitor for disease progression. While autonomic data is routinely collected and is available from these scans, these data are rarely, collected and analyzed; however, our group has shown feasibility. Therefore, autonomic data is usually unavailable in children. Despite the availability of agerelated normal values, the predictive power of autonomic activity is understudied in children and there are no published studies of quantification of autonomic data in this population.

NCT ID: NCT06107491 Completed - Depression Clinical Trials

Preoperative Educational Videos on Maternal Stress Whose Children Received Congenital Heart Disease Surgery: During COVID-19 Panic

Start date: October 4, 2021
Phase: N/A
Study type: Interventional

During COVID-19 panic, we examined if educational digital video disk can reduce maternal uncertainty, anxiety and depression if their children undergo congenital heart disease surgery and when surgical or post-surgical complications occur. Compared to only routine education, adding digital video disk could decrease mothers' uncertainty and anxiety more after education, and until the day of discharge. Compared to only routine education, adding digital video disk could decrease mothers' uncertainty and anxiety more on the discharge day if their child had surgical or post-surgical complications.

NCT ID: NCT06089902 Recruiting - Clinical trials for Congenital Heart Disease

European Prospective Registry on Anomalous Aortic Origin of the Coronary Arteries

EUROAAOCA
Start date: January 1, 2019
Phase:
Study type: Observational [Patient Registry]

Anomalous aortic origin of a coronary artery (AAOCA) is a group of rare congenital heart defects with various clinical presentations. The lifetime-risk of an individual living with AAOCA is unknown, and data from multicentre registries are urgently needed to adapt current recommendations and guide optimal patient management. The European Registry for AAOCA (EURO-AAOCA) aims to assess differences with regard to AAOCA management between centres.

NCT ID: NCT06088680 Completed - Cardiac Anomaly Clinical Trials

Post Market Observational Retrospective Study of Glycar Bovine Pericardial Patch (CIP-003)

Start date: September 26, 2023
Phase:
Study type: Observational

The overall purpose of this observational Post Market Clinical Follow Up (PMCF) study is to ensure continued acceptability of the benefit risk ratio by assessment of safety and performance, in patients undergoing cardiovascular repair or reconstruction surgery under standard clinical care with the commercially available Glycar Pericardial Patch.

NCT ID: NCT06081855 Not yet recruiting - Clinical trials for Congenital Heart Disease

Predictors of Aortic Root Dilatation in Tetralogy of Fallot Patients

Start date: January 1, 2024
Phase:
Study type: Observational

- To predict vulnerable patients for aortic root dilatation in TOF patients using CT as a reliable imaging modality, thus aiding early intervention, and identifying those who will require strict follow-up. - To assess the prevalence of TOF patients who developed aortic root dilatation, and those who were complicated with dissection, AR, and aneurysm, through collecting data from a large center (Aswan Heart Centre). - To investigate the relationship between age at repair and the diameter of aortic root.

NCT ID: NCT06080074 Not yet recruiting - Heart Failure Clinical Trials

Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The goal of this multicenter observational clinical trial is to evaluate the safety and effectiveness of the Cardiohelp System for VA-ECMO in children with cardiac failure. The main question[s] it aims to answer are: - What is the safety and effectiveness of the Cardiohelp device for pediatric ECMO? - What are the optimal performance specifications of the Cardiohelp device in children? Should the Cardiohelp device be FDA-cleared for children? Children who are receiving the Cardiohelp device will be approached and consented to participate if interested. Participants will undergo a standardized data collection to estimate survival to 30 days and the prevalence of serious adverse events like stroke, bleeding, and hemolysis. Outcomes will be compared to performance goals (PG) derived from the ECMO literature. Funding Source -- FDA OOPD (Office of Orphan Product Development)

NCT ID: NCT06078943 Recruiting - Clinical trials for Congenital Heart Disease

ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood

Start date: March 17, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to validate performance claims for method comparison for ABL90 FLEX PLUS in heparinized neonatal arterial, venous, and capillary whole blood for ctBil and FHbF in a Point of Care (POC) setting.