Tetralogy of Fallot

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 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.

Pediatric patients undergoing cardiac surgery, particularly those with ventricular septal defect or tetrology of Fallot, experience significant physiological changes during surgery and cardiopulmonary bypass CPB. Traditional monitoring focuses on large blood vessels, but this may not reflect the true state of smaller vessels. Researchers are evaluating a handheld device called the Cytocam incident dark-field IDF microcirculatory camera, which provides real-time video and data of the microvascular circulation in these patients. This observational study involves using the Cytocam device to monitor microvascular blood flow at specific times after intubation in the operating room, 10 minutes after CPB starts, after the cross clamp is placed, hourly during CPB, after CPB ends, and every 4 hours during the first 48 hours in the intensive care unit. The study includes patients with cyanotic physiology related to tetrology of Fallot and those with acyanotic lesions undergoing ventricular septal defect repair. Participants will be monitored continuously using the Cytocam device during the surgical and recovery periods. Researchers will assess measures such as capillary density, microcirculatory flow index, tissue perfusion surrogates, and signs of acute kidney injury. Secondary outcomes include ventilator duration and adverse events. The study will follow patients for the first 48 hours after surgery to gather these data and understand microvascular changes during and after cardiac surgery.

Tetralogy of Fallot and double outlet right ventricle are congenital heart conditions that can lead to heart failure. Researchers are studying whether the medicine Propranolol can help increase the growth of new heart muscle cells in infants with these conditions. This study is a phase 1 randomized trial aiming to understand if Propranolol can reactivate heart muscle cell division and support normal heart growth in infants up to about 4 months old undergoing surgical repair. Participants will be randomly assigned to receive either Propranolol or a placebo starting at 1 month of age until 4 months or just before surgery. Propranolol will be given by parents in four daily doses based on the infants weight. Additionally, patients will receive labeled N-thymidine by mouth for five days to help measure heart muscle cell growth. The study includes heart imaging using echocardiogram and cardiac MRI before and at surgery, as well as tissue and blood sample collection during surgery for detailed analysis. During the study, infants will have regular physical exams including vital signs and feeding and diaper diaries to monitor medication processing. Researchers will analyze heart tissue removed during surgery to measure new heart muscle cell growth using isotope mass spectrometry. The main outcome is cardiomyocyte division at surgery. Secondary outcomes include heart muscle size changes assessed by imaging and microscopy. Participants will be monitored from 1 month of age until surgery, with close follow-up and safety assessments during this time.

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.

Tetralogy of Fallot ToF is a congenital heart defect characterized by four major features, including obstruction of the right ventricular outflow tract. About 25 children in Denmark are born with ToF each year, and corrective surgery is typically done within the first year of life. Many patients require enlargement of the outflow tract with a patch, which can lead to severe pulmonary regurgitation and later complications like right ventricular dysfunction and arrhythmias. This trial aims to evaluate the long-term outcomes after initial ToF repair and to determine the best timing for pulmonary valve replacement in patients with free pulmonary regurgitation. The study will enroll 500 patients in a multicenter, cross-sectional evaluation, with 120 patients who have free pulmonary regurgitation randomized into two groups. One group will undergo early pulmonary valve replacement within 3 months after randomization, while the other will have the procedure later when they meet current European guideline criteria. The valve replacement involves surgical implantation of an adult-sized homograft or Contegra graft under cardiopulmonary bypass through a sternotomy. Participants will be followed for at least 10 years to assess long-term safety and effectiveness. Participants will be monitored regularly with yearly assessments including heart function measurements by MRI, exercise testing, arrhythmia monitoring, quality of life evaluations, and health system contacts. Primary outcomes include right ventricular end-diastolic volume indexed to body surface area and mortality rates measured 3 years after randomization. Secondary outcomes cover additional cardiac function parameters, complication rates after surgery, stroke and mortality rates, and quality of life changes over 10 years. The study also tracks valve deterioration and other clinical events to gain comprehensive information on the impact of early versus later re-valving.

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.

Researchers are studying individuals with repaired Tetralogy of Fallot rTOF who remain at risk for sudden cardiac death due to ventricular tachycardia VT. This study aims to understand how transcatheter pulmonary valve replacement TPVR affects the hearts electrical pathways, specifically the right ventricular RV isthmuses, and to explore new technology for mapping heart electrical activity. The goal is to better identify and characterize areas at risk during TPVR procedures. Participants will undergo TPVR as part of their standard care. Before the valve is placed, a detailed 3-dimensional electroanatomic map of the RV will be created using a specialized high-density catheter and mapping system. This mapping includes overlaying prior imaging and assessing heart electrical activity during normal rhythm and paced heartbeats. No attempts will be made to induce arrhythmias or perform ablation during the procedure. After the procedure, participants will be followed for 10 years to track heart rhythm events such as ventricular tachycardia, ventricular fibrillation, ICD placement or shocks, and sudden cardiac arrest or death. Annual medical record reviews will support this long-term monitoring. The study measures the area of RV isthmuses affected by the valve immediately after TPVR and monitors arrhythmic events over time.

Researchers are evaluating how changes in right atrial reservoir strain RASr can help identify fluid responsiveness in patients with septic shock. The study focuses on determining if variations in RASr after a fluid challenge or passive leg raising PLR maneuver can predict increases in cardiac output. This is important for managing fluid treatment to avoid unnecessary administration in critically ill septic shock patients. Participants will undergo transthoracic echocardiography TTE at several time points before and after the PLR maneuver, and before and after a fluid challenge. These procedures are routine for septic shock care but will be repeated as part of the study to measure changes in cardiac output and RASr. The TTE is non-invasive, painless, and performed at the bedside with no known risks. During the study, patients will have TTE scans at baseline, and at 10, 30, and 45 minutes after fluid challenge or PLR. The main outcome measured is the change in RASr value after fluid challenge. Secondary outcomes include comparisons of stroke volume, central venous pressure, and right ventricular function. No additional follow-up or contact is required after the final TTE scan. The study concludes once all measurements are collected.