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Heart Defects, Congenital clinical trials

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NCT ID: NCT05869825 Not yet recruiting - Clinical trials for Congenital Heart Disease

HFNC vs NIPPV Following Extubation

Start date: May 2024
Phase: N/A
Study type: Interventional

This study has the goal to determine the best method of respiratory support following extubation after cardiac surgery (CS). After cardiac surgery for Congenital Heart Disease (CHD), patients remain intubated until the cardiac team determines it is safe for the patient to undergo a trial of extubation. Two common methods of respiratory support following extubation are High Flow Nasal Cannula (HFNC) and Non Invasive Positive Pressure Ventilation (NIPPV). There is currently a gap in data comparing High Flow Nasal Cannula and Non-Invasive Positive Pressure Ventilation in infants (age 0-1) in regard to extubation failure and overall outcomes. This study will monitor the health outcomes of 200 infants (0 - 1 year) with CHD following cardiac surgery in the Cardiac Intensive Care Unit (CICU) at Children's Healthcare of Atlanta (CHOA). This will be done by assigning the respiratory support method each child will receive following extubation after cardiac surgery. Health outcomes will be monitored until discharge or until the second instance of extubation failure. Both study arms are standard-of-care respiratory support methods in the CHOA CICU. The investigators aim to determine which of these two methods has fewer risk factors when used with infants.

NCT ID: NCT05852106 Not yet recruiting - Clinical trials for Congenital Heart Disease

The Effect of 3D Heart Modelling on Family Quality of Life and Surgical Success

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

Introduction and Objective: In recent years, 3D (three-dimensional) modeling has been added to traditional and effective diagnostic methods such as Computed Tomography (CT), Magnetic Resonance Imaging (MRI), and Echocardiography. The purpose of this study is to determine the effectiveness of models created from patients' own radiological images using 3D printing technology in the clinical setting to simulate surgery in the preoperative period and provide preoperative parental education to improve family quality of life and positively influence patient outcomes. Methods: The study is a two-group pretest-posttest randomized controlled study. The children who come to the outpatient clinic examination in a private hospital and who are subjected to Computed Tomography (CT) examination for diagnostic procedures will be modeled in the experimental group, pre-tests will be applied, and the model will be 3D printed after it is approved by the radiologist who is among the researchers. The sample size is 15 experimental group and 15 control group. After the radiologist's approval, surgical simulation and preoperative education will be applied to the experimental group. The control group will receive the same parent education as the standard model. Both groups will complete the Sociodemographic Information Form, Surgical Simulation Evaluation Form - Part I, and Pediatric Quality of Life Inventory (PedsQL) Family Impacts Module one week prior to hospitalization. Surgical simulation and preoperative education will be completed on the same day. On postoperative day 0, only the Surgical Simulation Evaluation Form - Part II will be applied and on postoperative day 15, the Surgical Simulation Evaluation Form - Part II and the Pediatric Quality of Life Inventory (PedsQL) Family Impacts Module will be applied to both groups as a posttest. Pilot Study and Results: Modeling and 3D printing studies were conducted to carry out the study. A total of four diagnosed and treated patients were retrospectively analyzed. An intracardiac anomaly was detected in the patient data taken for the first model. It was decided to model the extracardiac structures since the inside of the heart was filled with blood, and the blood could not be ruled out as a solid structure. Finally, aortic coarctation was modeled clearly from the images taken and completed.

NCT ID: NCT05778175 Not yet recruiting - Clinical trials for Congenital Heart Disease in Children

Common Cases in Pediatric Intensive Care in Assuit University Cardiology Institute, a Clinical Audit

Start date: May 1, 2023
Phase:
Study type: Observational

1Evaluation of the management methods according to guidelines for cardiac patients admitted to Intensive care in pediatric Assuit university cardiology institute and the effectiveness and outcome of following of these medications comparing them with international advanced centers. Types of shocks in cardiac patients and management of cardiogenic shock needs especial concern.

NCT ID: NCT05687292 Not yet recruiting - Clinical trials for Congenital Heart Disease

Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery

Start date: September 2024
Phase:
Study type: Observational

The goal of this study is to evaluate the impact of a clinical decision support system (CDSS) in children receiving mechanical ventilation (MV) after surgery for congenital heart disease (CHD). The main question it aims to answer is: -What is the impact of a CDSS designed to facilitate weaning and discontinuation of MV on the duration of MV in post-operative congenital cardiac surgery patients? Participants will be identified as eligible to initiate weaning from mechanical ventilation. Providers will decide whether or not to initiate weaning based on recommendations provided by the CDSS. Researchers will compare patients exposed to the CDSS with a historical cohort to see if the CDSS facilitated a decrease in MV duration.

NCT ID: NCT05670132 Not yet recruiting - Clinical trials for Congenital Heart Disease

Neuro-cardiac Rehabilitation in Youth With Congenital Heart Disease (QUALINEUROREHAB)

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

Remarkable progress in paediatric cardiology and surgery have led to the substantial increase of congenital heart disease (CHD) survivors. Long-term outcomes in rare and complex CHD have become a critical priority as three major sources of morbidity have been identified in this population: neurodevelopmental sequelae, mental health issues and reduced exercise capacity. These challenges adversely affect their quality of life and constitute a major public health issue. We seek to evaluate the efficacy of the first integrative and holistic program in Neuro-Cardiac Health associating physical and psychological rehabilitation for children with rare CHD compared to the standard of care. Children randomly assigned to the intervention will undergo a 12-week neuro-cardiac intervention including home-based adaptive physical exercise, telehealth parent and child psycho-education and child computerized cognitive training, as well in-person individual sessions of intervention reinforcement. Parents will be actively involved and will receive personalized feedback and educational resources. Children assigned to the control group will receive the standard of care in congenital cardiology. Post-intervention effects will be measured after 12-months on several outcomes including health-related quality of life (HRQoL), trained and untrained cognitive skills, mental health outcomes and cardiovascular/physical variables.

NCT ID: NCT05580510 Not yet recruiting - Heart Failure Clinical Trials

" Evaluation of Safety and Efficacy of Empagliflozin and Sacubitril/Valsartan for CHF With Reduced Ejection Fraction in ACHD "

Start date: February 6, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The treatment of adult patients with congenital heart disease (ACHD) and heart failure (HF) represents a great challenge since, to date, there is no standardized guideline for this specific population. Although new treatments for HF have been proposed, such as Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors and neprilisin and angiotensin receptor inhibitors, the benefit of these drugs in patients with HF associated with congenital heart disease in adults has not yet been demonstrated. For this reason, this study pretends to evaluate the efficacy of empagliflozin and sacubitril/valsartan in this population.

NCT ID: NCT05568849 Not yet recruiting - Clinical trials for Congenital Heart Disease

Optical Coherence Tomography Angiography (OCTA) in Children's Cardiac Surgery

OCTA
Start date: October 2022
Phase: N/A
Study type: Interventional

Around 3500 children including 1,000 babies a year in the UK require heart surgery. Open-heart repairs involve the heart being stopped, while blood is pumped around the body using a cardiopulmonary bypass machine. Following complex operations, the patient may temporarily develop poor heart function, leading to reduced organ blood supply. Low heart output leads to post-operative complications or even death. The current methods to assess cardiac output and to see if vital organs, especially the brain, are receiving enough blood flow, are indirect and can be inaccurate. If we find a better way to detect and then avert or ameliorate periods of poor cardiac output and / or reduced brain perfusion, then this would be helpful for clinicians and could lead to better outcomes for children. We believe that optical coherence tomography angiography (OCTA), a non-invasive way to image the blood vessels in the retina at the back of the eye, could help us to assess cardiac output and brain perfusion. The OCTA machine was approved for use in humans in 2019 and given a CE Marking, but it has previously been used mainly in the management of eye diseases. There is a small amount of experience with its use in critically ill adults. We plan a pilot study to see if it is possible to use the OCTA machine at key time points, before, during and after children's heart operations, in 30 patients. We will study the images taken with OCTA machine to see if they are of good quality and we will analyze the images to see whether or not the expected changes in cardiac output and brain perfusion that occur with heart surgery can be detected as changes in blood flow in the back of the eye. Depending on the success of this pilot, we will plan further studies.

NCT ID: NCT05546008 Not yet recruiting - Clinical trials for Congenital Heart Disease

Comparison Between Multislice CT and Echocardiography in Diagnosis of Pediatric Congenital Heart Disease

CHD
Start date: September 10, 2022
Phase:
Study type: Observational

1. Assesment of pediatric CHD by Echocardiography and Multislice CT before operation and compare with surgical results. 2. Compare echocardiogram and 128-Multislice spiral computed tomography(MSCT) in the diagnosis of pediatric CHD. 3. Confirm echocardiographic finding in pediatric CHD by(MSCT) and to show the role of MSCT in diagnosing of extra-cardia anomalies. 4. to show the role of MSCT as a useful tool in defintive diagnosis of congenital heart disease before operations which assist surgeons

NCT ID: NCT05536310 Not yet recruiting - Clinical trials for Aortic Valve Stenosis

TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease

TAVIS
Start date: March 2023
Phase:
Study type: Observational [Patient Registry]

To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).

NCT ID: NCT05524324 Not yet recruiting - Clinical trials for Congenital Heart Disease

Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT

RIGHT-CRT
Start date: September 2022
Phase: N/A
Study type: Interventional

The main objective of RIGHT-CRT is to assess the impact/efficacy of CRT on functional capacity in ACHD patients with SRV.