View clinical trials related to Congenital Heart Disease.
Filter by:This study is being done to determine the mechanism(s) contributing to the onset of symptoms (i.e. shortness of breath and/or palpitations) as well as changes in heart structure in patients with congenital heart disease (CHD)
Almost 1% of infants are born with Congenital Heart Disease (CHD), an umbrella term referring to a range of anomalies in the heart's structure that are present at birth. Owing to significant medical advances, it is now estimated that more than 90% of persons born with CHD will reach adulthood. Children with CHD and their families' mental health outcomes need for psychosocial care. This study will intend to improve the psychological functioning of children, adolescents with CHD and their parents. The research will comprise of two major studies. The sample of first study will be based on a Cohort (From April 2021 to October 2021) of children, adolescent and their parents. Participants will be assessed for their psychological functioning and health related quality of life using Strength and Difficulty Questionnaire, pedsQL 3.0 cardiac module , Parental Stress Index , and 36-Item Short Form Survey. It is hypothesized that parental psychological functioning will mediate the relationship between psychological functioning of children and adolescent with CHD and their health related quality of life. It is also hypothesized that emotional behavioral issues of children and adolescents will moderate the link between parental psychological functioning and their quality of life. Illness parameters and sociodemographic correlates will serve as covariates in the study. This study will provide a baseline for the second study that is expected to use a randomized control trial of an intervention program based on training workshops derived from CHIP for the reduction in parental distress, emotional behavioral problem and improvement in health related quality of life among children, adolescent with CHD and their parents. The pretest-posttest design will be used. The randomized control trial will be conducted as per Consort Guidelines. A sub sample will be selected from the initial study using purposive sampling. Intervention study will include a subsample of CHD population (60 children and adolescents each) and their parents using purposive sampling technique. The participants will be randomly assigned to experimental & control groups. Illness related and demographic parameters will be distributed equally in both groups for establishing control. The intervention will be administered to experimental group only, while control group will receive regular treatment. Results of Pretest and posttest measures will be statistically analyzed. The designed intervention program (using problem solving therapy, psycho-education and Parenting the child with CHD training) will lower the level of parental stress in parents and emotional behavioral issues in CHD population. It will further increase the level of health related quality of life among children and adolescent with CHD and their parents. The research will incorporate psychosocial care with CHD population along with their regular treatment and thus improve their future health related outcomes in Pakistan.
The study to be performed aims to design and develope an automated Intelligent Decision Support System for fetal echocardiography that can significantly assist the obstetric physician in the improvement of detection of fetal congenital heart disease compared to the common standard of care.
With stress echo (SE) 2020 study, a new standard of practice in stress imaging was developed and disseminated: the ABCDE protocol for functional testing within and beyond CAD. ABCDE protocol was the fruit of SE 2020, and is the seed of SE 2030, which is articulated in 12 projects: 1-SE in coronary artery disease (SECAD); 2- SE in diastolic heart failure (SEDIA); 3-SE in hypertrophic cardiomyopathy (SEHCA); 4- SE post-chest radiotherapy and chemotherapy (SERA); 5- Artificial intelligence SE evaluation (AI-SEE); 6- Environmental stress echocardiography and air pollution (ESTER); 7- SE in repaired Tetralogy of Fallot (SETOF) ; 8- SE in post-COVID-19 (SECOV); 9: Recovery by stress echo of conventionally unfit donor good hearts (RESURGE); 10- SE for mitral ischemic regurgitation (SEMIR); 11- SE in valvular heart disease (SEVA); 12- SE for coronary vasospasm (SESPASM). The study aims to recruit in the next 5 years (2021-2025) ≥10 000 patients followed for ≥5 years (up to 2030) from ≥20 quality-controlled laboratories from ≥10 countries. In this COVID-19 era of sustainable health care delivery, SE2030 will provide the evidence to finally recommend SE as the optimal and versatile imaging modality for functional testing anywhere, any time and in any patient.
The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.
The aim of this clinical prospective study is to investigate the value of fetal cardiac magnetic resonance imaging using a new Doppler ultrasound based gating method for the detection of congenital heart desease.
Our study is about to follow adult congenital patients, known with systemic right ventricle (mostly correct transposition of the great arteries ou congenitally corrected transposition fo the great arteries) and systemic valve severe regurgitation which was treated with a Mitraclip device on this tricuspid valve. It's an observationnal study with a 2 years follow up with clinical (symptoms, complications, VO2 exercice test) echographic and MRI outcomes .
Infants and children with heart conditions require treatment in children's hospitals that are typically located in large cities. This creates challenges for children and families who need to travel long distances to come to appointments. Providing quality care to children with heart disease has further been challenged by the COVID-19 pandemic, with a shift towards decreased in-person contact and an increase in virtual visits, where assessment by doctors and nurses is more limited. This research study will look at how families of children with heart disease access care and how investigators can improve care with virtual technologies. This will involve testing a new home-based virtual care platform that uses Bluetooth technology to connect weight scales, oxygen measuring devices and blood pressure cuffs with a smartphone app, allowing parents to easily use these devices and send accurate data directly to the cardiology team. Investigators will obtain feedback from families, patients, and healthcare providers about how this helped or did not help them, and adjust the technology as needed to make it better.
Prospective, single-arm, multi-center study to evaluate safety and effectiveness of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement. The Autus Valve may be expanded pre-implant to match the subject's body size. Subjects will be evaluated prior to the Autus Valve implant procedure, immediately post-implant, at hospital discharge, 30 days, 6 months, and annually through 10 years. The Autus Valve may be expanded post-implant via transcatheter balloon dilation to accommodate growth of the subject. In subjects who undergo a post-implant valve expansion, follow-up will continue for a minimum of 1 year after the post-implant valve expansion procedure.
Background & Significance. Children with congenital heart disease (CHD) have experienced improved postoperative survival shifting the focus away from minimizing mortality to curtailing morbidities. Critical illness following cardiac surgery induces catabolism which may impact functional status. Catabolism, a state in which protein breakdown exceeds protein synthesis, can lead to lean body mass (LBM) breakdown. LBM loss has been associated with poor clinical outcomes. Muscle ultrasound (mUS) has been utilized to measure LBM changes and the functional status score (FSS) was developed to assess functional status changes in children following hospitalization. The ability to identify LBM loss acutely and its association with FSS changes may lead to earlier interventions to preserve LBM and aid in outcome prediction. Specific Aims & Hypotheses. Specific Aim 1 is to identify the percent change in LBM by mUS during the first postoperative week in children following complex cardiac surgery. Specific Aim 2 is to evaluate the relationship between percent change in LBM during the first postoperative week and the FSS at discharge and 6 and 12-month follow-up in children with CHD following complex cardiac surgery. The investigators hypothesize children with CHD following complex cardiac surgery will experience a decline in LBM and that there is a direct relationship between the change in LBM and postoperative FSS follow-up. Study Design & Methods. The investigators are conducting a single-center, prospective, observational cohort study. Consecutive children (> 3 months and < 18 years of age) with CHD undergoing biventricular conversion will be enrolled. Patients will undergo a baseline mUS and FSS at the time of the index operation. Interval mUS will be obtained on the third and seventh postoperative day. Discharge mUS and FSS will be obtained and a remote FSS will be requested by the family at 6 and 12-months postoperatively. Demographics, pertinent laboratory, concomitant medications, nutrition and ultrasound variables will be collected. Outcomes. The primary outcomes will be change in LBM during the first postoperative week and change in FSS at 6 and 12-month follow-up in children following complex cardiac surgery. Change in LBM will be defined as a percent change in cross-sectional area of the quadriceps muscle layer thickness (QMLT). Change in FSS will be significant if the score drops 3 points or more from baseline at postoperative follow-up.