Congenital Heart Disease

Researchers are evaluating a new 10-minute cardiovascular magnetic resonance (CMR) imaging protocol designed to improve current CMR procedures for patients with various heart conditions, including coronary artery disease, cardiomyopathies, and other cardiac diseases. The study aims to develop a standardized, contrast-free imaging method that can be applied to about 70% of cardiac patients. The goal is to assess whether this shorter protocol enhances diagnostic decision-making and reduces healthcare costs. The study involves two groups: healthy volunteers over 18 years old without significant cardiovascular or respiratory conditions, and patients over 18 years who require a clinically indicated CMR exam. The new protocol focuses on heart function and tissue characterization without using contrast agents. Researchers will compare the new 10-minute protocol to standard CMR imaging, evaluating its clinical feasibility, performance, and cost-effectiveness in different patient populations. Participants will undergo CMR scans using both the new and standard protocols. Researchers will monitor diagnostic results, scan completion rates, scan sequence times, adverse events, and cost differences between methods. Various heart tissue measurements and reproducibility between different readers and scanners will also be assessed. The study spans from 2019 to 2025, with ongoing safety monitoring during imaging sequences and a focus on improving the efficiency and quality of cardiac imaging.

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 person's 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.

Migraine is a common chronic neurological condition linked to patent foramen ovale (PFO), a frequent congenital heart defect in adults. This research investigates the connection between PFO and migraines, focusing on the effects of closing the PFO to reduce migraine symptoms. Previous studies suggest that closing the PFO with metal devices can reduce migraine days but may also cause new or worsened migraines due to permanent metal implants. The study aims to compare outcomes using a new biodegradable PFO occluder versus a traditional metal occluder. Participants will be randomly assigned to receive either the innovative MemoSorb4 biodegradable occluder, which dissolves over time to avoid complications of metal implants, or the conventional metal occluder device. The biodegradable occluder acts as a temporary bridge that gradually degrades while the heart tissue repairs itself. This single-blind, controlled trial will evaluate the safety and effectiveness of these two devices in patients with both PFO and migraine. During the study, participants will be monitored for migraine frequency and severity, with the main outcome being the reduction in migraine days per month measured at 12 months after the procedure. Follow-ups will include clinical evaluations and diagnostic testing to assess device performance and migraine relief. The total study duration and safety monitoring will span at least one year post-implantation to compare long-term effects of the two occluder types.

Researchers are conducting an observational study to gather information on the prevalence, treatment, and outcomes of congenital heart disease (CHD) throughout patients' lives in China. The study focuses on various stages, from fetal diagnosis to early treatment of severe CHD in newborns, and includes standardized care for pregnant patients with CHD. The aim is to improve diagnosis and treatment at participating hospitals, especially for complex cases, and to promote uniform clinical practices in cardiovascular care across China, ultimately enhancing medical service quality and informing national treatment guidelines. The study will be carried out by Beijing Anzhen Hospital and the National Clinical Research Center for Cardiovascular Diseases, involving over 20 hospitals over five years. Starting January 1, 2024, each hospital will collect data on CHD inpatient cases monthly. A dedicated website will support data collection, education, training, and experience sharing. The project includes regular analysis and reporting of quality indicators, with guidance and support provided to hospitals to address issues and improve care. Hospitals showing excellence and improvement will be recognized to encourage overall quality advancement. Participants will be patients diagnosed with various forms of congenital heart disease. The study will monitor outcomes including mortality within the first week after surgery, rates of integrated prenatal and postnatal diagnosis and treatment, surgical intervention rates in newborns, and medium- to long-term survival and reoperation rates up to five years after discharge. Data collection will continue monthly, with ongoing education and quality improvement efforts, and the study is expected to last until January 1, 2030.

Researchers are evaluating a predictive tool called the Multifactorial Dynamic Perfusion Index (MDPI) to estimate the risk of acute kidney injury after cardiac surgery involving cardiopulmonary bypass (CPB). This observational study involves adults and infants undergoing cardiac surgery, aiming to validate the MDPI in adults, develop a version for infants under 20 kg, and explore if the MDPI can predict other complications including mortality. The MDPI combines seven variables measured during CPB, many of which can be modified by the surgical team to potentially improve patient outcomes. The study is divided into three parts: first, validating the MDPI in 800 adult cardiac surgery patients from two centers using existing CPB monitors that collect data such as hematocrit, oxygen delivery, arterial pressure, and transfusions; second, developing a modified MDPI for 200 infants under 20 kg undergoing congenital heart surgery with additional infant-specific variables; and third, investigating whether the MDPI can predict other postoperative issues like low cardiac output, longer ICU stays, bleeding complications, and 30-day mortality. Data collection includes parameters recorded during surgery and postoperative creatinine values. Participants will undergo cardiac surgery with CPB, during which relevant physiological data will be continuously recorded by specialized monitors. After surgery, kidney function and other outcomes will be monitored for up to 48 hours, with extended follow-up for complications and mortality over 30 days. Researchers will analyze how well the MDPI predicts acute kidney injury and other clinical outcomes, aiming to incorporate the MDPI into real-time monitoring devices to guide therapeutic decisions during surgery.

This research aims to evaluate the feasibility of a parent-child yoga intervention designed to reduce attention deficits in children aged 4 to 6 years with congenital heart disease (CHD). Children with CHD often face neurodevelopmental challenges, including a higher risk of attention deficit hyperactivity disorder (ADHD). This study is a preliminary step before conducting a larger randomized controlled trial (RCT) to test the effectiveness of this intervention in improving attention and long-term academic and psychosocial outcomes for these children and their families. The study is a single-blind, two-center, two-arm randomized feasibility trial involving 24 parent-child pairs. Participants will be randomly assigned in a 2:1 ratio to either an 8-week parent-child yoga program plus standard clinical care or standard clinical care alone with a waitlist option for yoga after the study. The yoga sessions last 45 minutes each week and include active and calming parts embedded in stories suitable for the child's developmental level. Parents and children will also be encouraged to practice 5-minute at-home exercises three times a week throughout the 8-week period and continue up to a 6-month follow-up. Participants will undergo three neurodevelopmental assessments: before the intervention, immediately after, and six months later. The study will monitor recruitment, dropout, and adherence rates; acceptability of randomization; variation in yoga delivery; and data completeness. These measurements will help determine the feasibility of the procedures and inform the sample size for the future full-scale RCT. Overall participation spans about eight months including the intervention and follow-up periods.

Researchers are evaluating the ability to detect blood flow and heart function abnormalities in patients with congenital heart disease using invasive hemodynamic assessments at rest and during exercise. The study aims to compare how well invasive measurements match noninvasive Doppler methods and to see how these measurements relate to disease severity. This research is sponsored by the Mayo Clinic and focuses on improving assessment techniques for congenital heart disease. Participants will undergo a standard cardiac catheterization procedure alongside an invasive cardiopulmonary exercise test during the same procedure. This combined testing will measure heart and blood vessel function at rest and during peak exercise to capture changes in heart muscle stiffness, cardiac output, vascular resistance, and strain on the right ventricle. The intervention involves one study group consisting of patients undergoing clinically indicated cardiac catheterization with the added exercise testing. During the study, participants will be closely monitored through invasive measurements collected during their catheterization and exercise testing. Researchers will evaluate changes from rest to peak exercise in multiple heart function indicators, including left and right ventricular output, systemic and pulmonary vascular resistance, and ventricular strain. The study will last until December 2026, and the data collected will help understand heart function during exercise in congenital heart disease patients.

This research aims to provide comparative data for the Mayo Clinic Adult Congenital Heart Disease Registry by studying both healthy individuals and those with congenital heart disease. The study is observational and focuses on gathering important baseline information related to heart and lung function. Participants will be observed without receiving any specific treatment or intervention. The study involves collecting data to measure pulmonary vascular reserve at baseline, which helps researchers understand heart and lung blood flow under different conditions. During the study, participants will undergo assessments such as MRI scans and blood pressure measurements. Kidney function will be confirmed through recent lab results. Participants will be monitored for factors that might influence the heart and lung function measurements. The study is expected to continue until December 2026, with ongoing data collection at regular intervals.

Researchers are evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary effectiveness of an anti-GPRC5D CAR-T cell product called OriCAR-017 in adults with relapsed or refractory multiple myeloma. This Phase I/II open-label study is the first clinical trial of OriCAR-017 in the United States by OriCell Therapeutics Co., Ltd., aiming to find suitable dosing and assess early treatment results in this patient group. The study includes a Phase I dose escalation stage with three different doses given as a single intravenous infusion to up to 18 participants. This is followed by a dose expansion stage with 10-15 participants and then a Phase II stage that may include up to 48 participants. Each participant receives one infusion of OriCAR-017 to evaluate its effects and safety. Participants will be closely monitored for up to two years after treatment. Researchers will assess the maximum tolerated dose and dose-limiting toxicities within 28 days after infusion. They will also study how the drug moves through and affects the body, measure response duration, progression-free survival, overall survival, and other response rates. Regular evaluations include laboratory tests, clinical assessments, and safety monitoring throughout the study period.

Researchers are evaluating the safety and performance of Abbott's Structural Heart devices used in routine hospital practices and standard-of-care procedures for patients with various heart conditions such as atrial septal defect, muscular ventricular septal defect, patent foramen ovale, and valvular heart disease. This observational registry collects real-world data to meet regulatory requirements, including the European Union Medical Device Regulations 2017/745, which mandate active post-market follow-up of commercially available devices. The study includes patients who undergo implant attempts with Abbott Structural Heart devices like the Amplatzer Occlusion Devices and Epic Surgical Tissue Heart Valve devices. Patients may be enrolled before or shortly after their procedure, with different timelines depending on the device used. Follow-up visits align with each site's routine standard-of-care schedules and can be conducted in person, by phone, or virtually. Follow-up durations vary by device, ranging from discharge or 7 days post-procedure up to 10 years to monitor device performance and safety. Participants will provide informed consent and undergo data collection during their follow-up visits, which may include routine clinical assessments and monitoring consistent with standard care. The study tracks primary safety and effectiveness endpoints at 7 days and baseline, respectively. Approximately 500 subjects are expected to enroll each year across about 25 sites worldwide, and some sub-studies focus on specific surgical valve sizes. The total participation duration varies based on device type and follow-up requirements.