Clinical Research Directory

Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction

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).

Long-term Effects of Family WISH Program for Adolescents With Congenital Heart Disease

The goal of this clinical trial is to learn the long-term effects of "Family Walking Instruction with Support by Heart" (Family WISH) on frailty state, quality of life and family functioning among adolescents with congenital heart disease (CHD). Researchers will compare the 12-week Family WISH program, based on self-efficacy theory, to a comparison group receiving a family walking health education sheet to evaluate the long-term effectiveness of the Family WISH program. Participants will: * Walk with family members for 20-30 minutes daily, at least 5 times per week, totaling 150 minutes per week. * Keep a diary to record the frequency of their walks and any symptoms experienced. * Complete questionnaires at baseline, and at 6, 12, and 24 weeks.

Study on the Safety and Effectiveness of a Biodegradable Patent Foramen Ovale Occluder System

To evaluate the Safety and Efficacy of a Novel Biodegradable Occluder for Percutaneous Closure of Patent Foramen Ovale (PFO)

Genetics of Ventriculo-arterial Discordance

Number of centres planned : 16 centres in France Type of study / Study design : Research Involving the Human Person category 2. Multicentric. Prospective Planning of the study : Total duration: 57,5 months. Recruitment period: 33.5 months. Follow-up time per patients : 2 years Expected number of cases : The study will involve a maximum of 900 individuals, from 16 centers in France300 family trios (consisting of 150 index cases and their 2 parents, healthy volunteers, N= 450 individuals) \- In the event of unavailability, refusal, non-compliance with an inclusion or exclusion criterion concerning one of the biological parents, only the index case (patient) will be included in the study without his or her parents. The 300 index cases with ventriculo-arterial discordance will be divided into two groups: 100 double discordance cases and 200 large-vessel transpositions. These group inclusion targets are theoretical. If the proportion of patients available for inclusion turns out to be higher than expected for one of the groups, the targets may be adjusted, while maintaining a maximum of 300 cases included (corresponding to 900 subjects if all trios are complete). Patients and their parents will be informed of the study by their referring cardiologist, and their written consent will be obtained. Translated with DeepL.com (free version) Treatment, procedure, combination of procedures under consideration : * Blood samples for genetic analyses collected at the inclusion visit for patients and parents in case of trio families Schedule of different visits and examinations : Inclusion visit: * Collection of demographic, clinical data from the index case and parents * DNA sampling for genetic research (biocollection) of the index case or family trio * Completion of the quality of life questionnaire Annual visit with a 2 years follow-up: * Retrieval of data from the index case * Completion of the quality of life questionnaire

CHAMP App Cardiac Study and Repository

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.

Mind the Heart - Mental Health in Children and Adolescents With Congenital Heart Defects

The aim of the Mind the Heart study is to document the feasibility of an online parent/child administered screening model for mental disorders (MDs) in Danish children and adolescents with congenital heart disease (CHD). As MDs in children and adolescents with chronic somatic health issues are frequently underdiagnosed and undertreated, we further aim to develop a website with evidence based information on mental health in children and adolescents with CHD in order to promote knowledge and awareness among families and health professionals across sectors.

HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis

Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.

High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery

High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery

Development and Improvement of Home Rehabilitation Scheme for Preschool Children With Congenital Heart Disease After Operation

This part of the study focuses on understanding the home rehabilitation situation for preschool children with congenital heart disease after operation. Qualitative research interviews with caregivers and medical staff (including doctors, nurses, rehabilitation therapists, nutritionists, and psychologists) are conducted to explore the benefits, obstacles, and professional guidance needs of home rehabilitation. The aim is to summarize the best evidence for home rehabilitation through evidence-based nursing and qualitative research, in order to develop a more comprehensive and suitable home rehabilitation scheme for these children.

Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts

A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.

Global Utilization And Registry Database for Improved heArt preservatioN

The primary objective of this study is to collect real-world clinical performance data to assess the clinical outcomes of patients receiving heart transplants using donor hearts transported via the SherpaPak CTS System. These results will be compared to outcomes of retrospective patients whose hearts were transported with the previous standard method.

Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD

Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect

Congenital Heart Disease Physical Activity Lifestyle Study V.2

The Congenital Heart Disease Physical Activity Lifestyle Intervention Study (CHD-PALS) V.2 seeks to determine the efficacy of a lifestyle intervention program for adolescents and young adults (AYAs) with congenital heart disease (CHD). This trial was adapted from the original CHD-PAL trial to continue improving cardiovascular outcomes for transition-aged CHD survivors.

Genes Associated With Development of Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions

Pulmonary arterial hypertension (PAH) in patients with congenital heart disease (CHD) is associated with considerable morbidity and even mortality. Next to environmental risk factors, the investigators believe that there is an important role of genetic predisposition to develop PAH in CHD. There often is a discrepancy between the severity of PAH and the CHD, where it is useful to screen for PAH gene mutations. The investigators hypothesize that the genotype is partly responsible for the phenotypic variability in patients with congenital shunt lesions, where some develop PAH and others do not. If a genetic predisposition for PAH in CHD could be identified, then genetic screening could be a useful additional tool for early detection of patients at risk of pulmonary vascular disease and PAH development, with new opportunities for prevention or early treatment.

Effects of Rehabilitation Programme on Respiratory Function in Patients with Acquired and Intervened Congenital Heart Disease.

Congenital heart defects (CHDs) are heart malformations that occur before birth, and they represent one of the leading causes of neonatal morbidity and mortality. they occur in approximately 1% of newborns and are associated with high morbidity and mortality rates. The etiology of these cardiac anomalies is mostly unknown. around 70-80% of cases are generated by the involvement of multiple affected genes combined with an environmental trigger that, when acting on a susceptible individual, promotes the expression of the damaged genome. maternal diseases during pregnancy or exposure to teratogenic substances are also implicated in the etiology.

European Prospective Registry on Anomalous Aortic Origin of the Coronary Arteries

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.

DEX vs SEVO in Congenital Heart Surgery

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.