Active clinical trials for "Heart Defects, Congenital"

A prospective of 30 patients with symptomatic severe congenital valvular pulmonary stenosis who are indicated for percutaneous balloon pulmonary valvuloplasty . the aim is to - evaluate electrical and mechanical remodeling of RV 6 months following balloon dilation - evaluate Functional capacity using 6MWT and SaO2 before and 6 months following BPV

The overall goal of this program is to create a remote, mobile application enabled exercise program for patients with Congenital Heart Disease (CHD). Pilot trials will consist of a remote exercise program with app-embedded exercise modules designed to promote and encourage safe and healthy exercise habits across a range of CHD anatomies. This app-enabled program will allow for real time data collection integrating wearable devices, as well as compliance and safety monitoring to enhance research capabilities. The app-enabled program will be versatile and may be applied in the future to patients with non-cardiac conditions.

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.

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.

Anesthesia-related neurotoxicity in the developing brain is still a concern although evidence in humans is debatable. Moreover, it is unclear whether repeated and/or prolonged exposures are harmless and whether their effects are more pronounced in newborns and infants with brains more vulnerable to injury. One such specific group of patients is children with congenital heart disease (CHD). Nearly, half of the school-age survivors with CHD exhibit neurodevelopmental symptoms. It is thus important to elucidate whether any plausible neurotoxicity of the commonly used anesthetic agents can be observed in this population, and whether specific neuroprotective strategies can be demonstrated within the frame of a randomized controlled trial (RCT). Animal data have shown that dexmedetomidine (DEX) induces neuroprotective effects only at well-adjusted doses. One major issue with trials of anesthetic neurotoxicity is the latency between the conduct of these studies and the assessment of neurodevelopmental outcome. In contrast, the use of biomarkers of neuronal injury could be extremely valuable. Serum Neurofilament Light (NfL) has been shown to be a sensitive and specific marker of neuronal injury and is associated with neurologic outcome of children with various pathologies. The investigators hypothesize that in congenital heart surgery, use of DEX as main anesthetic agent in conjunction with low dose sevoflurane results in less release of serum NfL and is thus potentially less neurotoxic compared to the current standard of care. The hypothesis is tested with a RCT including patients between 0 - 3y undergoing surgery with cardiopulmonary bypass. To avoid any neurotoxicity due to anesthetic overdose, intraoperative burst suppression will be avoided. In addition to postoperative comparison of serum NfL, postoperative electroencephalogram and neurodevelopmental outcome of both groups will be compared taking into consideration the genetic background.

Introduction: The use of a nutritional protocols provides the standardization of assessment procedures and the optimization of nutritional status recovery of pre-surgical infants with Congenital Heart Disease (CHD). However, to our knowledge there are no validated instrument for presurgical nutritional support for infants with congenital heart disease (CHD) in Brazil. Objective: Assess the clinical effectiveness of the translated and cross-culturally adapted protocol, Nutritional Pathway for Infants with Congenital Heart Disease before Surgery (Marino et al., 2018), on the weight change of infants with congenital heart disease in two specialized cardiology hospitals in Southern Brazil in partnership with the UK research group that authored the original of protocol. Methods: A randomized, pragmatic clinical trial will be carried out. The sample will consist of children with CHD, between 0-12 months of age, awaiting cardiovascular corrective surgery from the Pediatric Outpatient Clinic in the Institute of Cardiology (IC) and Children's Hospital Santo Antonio of Santa Casa de Misericordia. The previously translated pre-surgical nutritional intervention protocol for infants with congenital heart disease will be compared with current routine nutritional guidelines used in the follow-up services of children with congenital heart disease in these institutions within the national public healthcare, SUS. Intended results: It is expected that the culturally-adapted pre-surgical nutritional support protocol for children with congenital heart disease will be effective in pre-surgical infant weight gain, which will likely improve surgical prognosis and clinical outcomes. And we hope that this protocol will promote the standardization of care, and will provide an empirically-based nutritional intervention that may improve the effectiveness of nutritional recovery in the CHD infants. Furthermore, the results may be used in the formulation of Brazilian guidelines for comprehensive care of children with congenital heart disease.

Establish a cardiovascular biomarker profile to help screening for congenital heart disease in infants and children as well as use non-invasive cardiac imaging in combination with such profiling to better predict the need for future cardiac interventions such as open heart surgery or cardiac catheter intervention selected types of with congenital heart disease.

The purpose of this study is to determine if a partial heart transplantation in patients with congenital heart disease is safe and feasible. Participants will have a partial heart transplant involving surgical replacement of the pulmonary valve with the heart valve and supporting blood vessels from an organ donor. The procedure, tests, medications, and follow-up visits will all be done per standard of care. Medical data will be collected to look at outcomes after surgery.

IntelliStent is intended to achieve reduction of pulmonary hypertension, improvements in symptoms and quality of life in adolescent and adult patients with congenital heart disease and dilated cardiomyopathy.

This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).