Transposition of the Great Arteries

Researchers are studying recovery after heart surgery for people with Complex Congenital Heart Disease CCHD to understand the main risk factors affecting recovery. The study also aims to build a comprehensive data platform to support CCHD care throughout a persons life and develop a China-specific quality control system to improve surgical outcomes and guide national health policies. The study includes two groups a retrospective group of 2,494 patients who already had CCHD surgery and are in an existing national database, and a prospective group of 1,940 patients scheduled for surgery as part of related sub-studies. Data collected include pre-surgery tests, surgical details, care during and after surgery, and follow-up for up to one year. Researchers will combine data from both groups to build a new registry and quality control system. Participants will have their medical records analyzed or have data collected during their care, depending on their group. Researchers will monitor recovery and outcomes up to one year after surgery, using the combined data to identify risk factors and develop a surgical quality control system. The study spans up to 48 months, aiming to improve CCHD care across all ages in China.

Researchers are studying the use of sodium-glucose cotransporter 2 inhibitors SGLT2i in adults with congenital heart disease ACHD, focusing on how these drugs are prescribed and their safety, tolerability, and possible benefits for heart failure-related outcomes. Heart failure is a leading cause of illness and death in this group, but treatment options are limited. SGLT2i are a new class of medications shown to help in conventional left ventricular heart failure and may work through multiple pathways to improve heart function. This international registry collects real-world data from adult ACHD patients who have been treated with any type and dose of SGLT2i. Data will be gathered from one year before starting the medication up to the most recent follow-up. There are no interventions or changes to care for participants since data collection uses routine clinical records. The registry aims to understand prescription patterns, side effects, discontinuation rates, and heart failure-related clinical and laboratory outcomes. Participants will contribute data from their medical records, including clinical parameters like weight, blood pressure, heart rate, oxygen saturation, laboratory values, echocardiography measurements, and exercise test results. Researchers will monitor safety and tolerability outcomes such as side effects, complications, and mortality over an average follow-up of one year. This study seeks to evaluate the impact of SGLT2i therapy on heart failure progression in ACHD patients through comprehensive real-world observation.

Researchers are investigating whether an integrated prenatal and postnatal treatment model improves outcomes for newborns with critical congenital heart disease CCHD compared to traditional care. This study aims to see if early diagnosis during pregnancy, combined with coordinated delivery and surgical planning, can reduce preoperative complications, optimize surgery timing, lower postoperative mortality, and enhance heart healing, especially in cases involving the right heart system. The goal is to improve treatment capacity and create guidelines suited to Chinas healthcare needs. The integrated model involves diagnosing CCHD by ultrasound at 22 to 26 weeks of pregnancy, transferring the mother within the hospital system before birth, and planning surgical care after multidisciplinary discussion. Newborns are transferred to the pediatric heart center immediately after birth for either urgent or elective surgery depending on their condition. Traditional care involves transferring newborns from outside hospitals with routine interventions. The study compares these two approaches by following patients from birth through surgery and afterward. Participants will be monitored during hospitalization, with evaluations of heart function, metabolic status, and survival rates over up to five years post-discharge. Researchers will assess 30-day postoperative mortality as the primary outcome and also look at heart failure before surgery, the proportion receiving integrated care, and long-term survival and reoperation rates. This real-world study uses hospital data from multiple sites to validate if the integrated prenatal-postnatal model offers better outcomes for newborns with CCHD.

Children with chronic health conditions have a higher chance of developing heart and blood vessel diseases earlier than their peers due to faster aging of these organs. Experts recommend careful monitoring and early care, but the exact causes of this increased risk are not well understood. This research seeks to better understand why these children face greater cardiovascular risks and to support future prevention efforts. The study observes children and young adults aged 6 to 25 who have chronic conditions linked to higher cardiovascular risk. It uses non-invasive methods to check the health of large blood vessels like the carotid artery and small vessels in the retina. These assessments include measuring arterial stiffness, endothelial function of the brachial artery, and retinal vessel features, all done at the start and during yearly follow-ups. Participants will undergo regular evaluations including scans of blood vessels and retinal imaging to monitor changes over time. The study measures key indicators such as arterial stiffness and retinal vessel diameter to track early signs of vascular aging. This ongoing observation helps researchers identify those at risk before obvious heart or vascular disease appears. The study is sponsored by Semmelweis University and runs until 2029, involving close monitoring without intervention.

Researchers are evaluating Cereset Research CR, a device-based intervention, to improve autonomic cardiovascular regulation in people aged 11 and older who experience symptoms of stress, anxiety, or insomnia. This open-label exploratory study aims to assess how CR affects heart rate variability, baroreflex sensitivity, and blood pressure variability. Secondary and tertiary objectives include examining changes in self-reported symptoms of insomnia, depression, anxiety, stress, and other related conditions, as well as exploring effects in specific subgroups with co-existing medical issues like PTSD, chronic pain, or prior stroke. Participants will receive between 4 and 12 sessions of CR, which uses audible tones echoing brainwave activity to provide real-time feedback. The intervention involves wearing sensors on the scalp while sitting comfortably with eyes closed. The upgraded CR system includes faster processing and fewer interruptions during sessions. Participants will continue their usual care throughout the study. Data collection will occur before and after the intervention, including physiological measures and symptom questionnaires. During the study, participants will attend an enrollment visit for baseline assessments, followed by the intervention period starting within 14 days. Follow-up assessments will take place 4 to 6 weeks after the final session to measure changes in autonomic function and symptoms. Researchers will also collect additional data on quality of life and specific condition-related outcomes. The study will monitor safety and gather information on medication effects, barriers to treatment, and participant experiences. Total participation duration varies based on the number of sessions received and follow-up timing.

This trial evaluates the safety and effectiveness of the Edwards Lifesciences SAPIEN 3 and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve THV Systems in people with a dysfunctional right ventricular outflow tract RVOT conduit or a previously implanted valve in the pulmonic position who need medical intervention. The study focuses on those with clinical indications for treatment to address pulmonary valve dysfunction and related heart conditions. Participants will receive transcatheter pulmonary valve replacement TPVR using either the SAPIEN 3 or SAPIEN 3 Ultra RESILIA THV devices. The study includes subjects with dysfunctional RVOT conduits, previously implanted surgical valves, or previously implanted transcatheter valves in the pulmonic position. Each participant undergoes TPVR as the main intervention. Throughout the study, participants will be monitored for outcomes such as valve dysfunction at one year, device success shortly after discharge, heart function measures at six months, and various safety events including vascular complications and bleeding within 30 days. The study involves follow-up visits for up to one year to assess heart valve performance, complications, and overall health status. The total study period extends until June 2031, with primary completion planned by December 2026.

Researchers are studying the effects of percutaneous interventions for branch pulmonary artery PA stenosis on exercise capacity in patients with dextro transposition of the great arteries d-TGA, Tetralogy of Fallot ToF, and Truncus Arteriosus TA. This randomized controlled trial also aims to assess the impact of these interventions on right ventricular RV function and to identify early markers to improve the timing of treatment. The study responds to the need for clearer guidelines on when to perform these interventions, as current knowledge about their effects on exercise capacity and heart function is limited. Participants are divided into two groups one undergoing percutaneous stent placement for PA stenosis and a control group receiving conservative management with potential delayed intervention. Both groups will receive standard care evaluations, including transthoracic echocardiogram TTE, cardiopulmonary exercise testing CPET, and cardiac magnetic resonance imaging CMR. The interventional group will have additional low dose dobutamine stress MRI at certain centers and RV pressure measurements during the intervention. Quality of life questionnaires will be collected at baseline and shortly after intervention or corresponding time points in controls. Long-term follow-up with TTE, CPET, and CMR will occur within 2 to 4 years. During the study, participants will undergo examinations at baseline and approximately six months later to measure exercise capacity VO2 max, RV function, and adaptation. Assessments include imaging, exercise testing, and questionnaires to evaluate heart performance and quality of life. Researchers will compare results between groups to determine the effects of the intervention. Safety and technical success will also be monitored through pressure and gradient measurements. The total study duration includes initial assessments, intervention or observation periods, and extended follow-up to understand long-term outcomes.

This research aims to evaluate the safety and potential benefits of the MASA Valve in children and young adults under 22 years old who require reconstruction of the Right Ventricular Outflow Tract RVOT due to congenital heart conditions such as Pulmonary Stenosis, Tetralogy of Fallot, Truncus Arteriosus, Transposition of Great Vessels, Pulmonary Atresia, or those undergoing the Ross Procedure. This early feasibility study gathers initial data to support future studies or regulatory approval. Participants will receive the MASA Valve, a bi-leaflet pulmonary valved conduit made of ePTFE material with integrated leaflets designed to restore blood flow from the right ventricle to the pulmonary arteries while preventing backflow. The valve is surgically implanted to replace or reconstruct the RVOT, including replacement of dysfunctional pulmonary valves or conduits. This is a single-arm study where all participants undergo implantation with the investigational device. During the study, participants will be monitored over one year with follow-up visits to assess safety and device performance, including freedom from device-related death, explant, reoperation, catheter interventions, endocarditis, thrombus, and major hemorrhage. Researchers will also evaluate valve function, pulmonary regurgitation, pulmonary gradient, and valve failure. Participants must be willing to return for follow-up visits and comply with study procedures throughout the trial period.

Researchers are conducting a multi-center randomized controlled trial to determine the best timing for surgery in newborns with Complex Congenital Heart Disease CCHD. The study aims to develop innovative treatment strategies for critically ill newborns with CCHD and establish a system to evaluate treatment effectiveness. The goal is to reduce perioperative death and non-recovery discharge rates by half, improving overall care standards for these newborns in China. The trial compares two surgical approaches operating on newborns younger than 7 days old and operating on those older than 7 days. Participants will be randomly assigned to one of these two groups. The study uses data from a national multi-center database and integrates prenatal and postnatal diagnosis to guide treatment. Newborns diagnosed with specific heart defects will be followed for one year after surgery. Researchers will monitor perioperative mortality and non-rehabilitation discharge rates. Participants and their families will complete related examinations and follow-up visits during this period to assess treatment outcomes and safety under medical supervision.

This research focuses on newborns with congenital heart defects CHD, who face changes in blood flow and oxygen delivery during their first week of life. Researchers aim to compare near infrared spectroscopy NIRS, a noninvasive method that measures oxygen levels in the brain and kidneys using skin stickers, with echocardiography, which uses ultrasound to assess heart function and blood flow. The study seeks to understand how well NIRS correlates with traditional echocardiographic measures in babies with CHD. The study involves placing NIRS probes on the newborns forehead and abdomen to continuously monitor oxygen saturation in the brain and kidneys for up to seven days or until the baby is discharged or undergoes cardiac procedures. Daily echocardiography exams lasting 15 to 20 minutes will also be performed during this period. Newborns with CHD admitted to the neonatal intensive care unit NICU will be recruited either during fetal consultations or after birth. Participants will be closely monitored through continuous NIRS readings and daily echocardiography scans. Researchers will analyze correlations between cerebral and renal oxygen saturation and Doppler ultrasound measures of blood flow and heart performance throughout the first week of life. The study plans to enroll about 100 newborns to better understand how cardiac conditions affect oxygen delivery during this critical transitional period.