Ventricular Septal Defect (VSD)

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.

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.

Researchers are studying the use of Cereset Research (CR), a device-based intervention, to improve autonomic cardiovascular regulation in people aged 11 and older who have symptoms of stress, anxiety, or insomnia. This exploratory, open-label study aims to assess how CR affects heart rate variability, baroreflex sensitivity, and blood pressure variability. Secondary goals include evaluating changes in self-reported symptoms such as insomnia, depression, anxiety, and stress, along with exploring impacts in subgroups with other conditions like traumatic brain injury or PTSD. Participants will receive between 4 and 12 sessions of CR, which delivers audible tones echoing brainwave activity through sensors placed on the scalp with eyes closed. The device uses a 64-bit processing system and switches between sensor pairs during sessions to reduce interruptions and session length. This single-arm trial does not use a control group, and participants continue their usual care throughout the study. Participants will be evaluated at enrollment and through follow-up visits up to 4 to 6 weeks after the final session. Assessments include physiological measures such as blood pressure and heart rate variability, plus questionnaires on sleep, mood, anxiety, stress, traumatic stress, and quality of life. Data will be analyzed to measure changes from baseline and to explore effects in participants with coexisting symptoms or conditions. The total study duration for each participant varies depending on the number of sessions and follow-up timing.

Ventricular septal defect (VSD) is one of the most common significant congenital heart defects, accounting for up to 40% of all cardiac abnormalities. It can occur alone or as part of more complex heart malformations such as tetralogy of Fallot, double-outlet right ventricle, transposition of the great vessels, aortic coarctation or interruption, and truncus arteriosus. This observational study aims to clinically evaluate VSD in children to better understand its characteristics and progression. The study involves using echocardiography (ECHO) to determine the type and size of the ventricular septal defect. Children diagnosed with isolated VSD or VSD accompanied by other cardiac anomalies will be observed. The primary outcome measure is the size of the VSD assessed over a 12-month period. Participants will be children from birth up to 16 years old, inclusive of both genders. The evaluation includes echocardiographic imaging to monitor the VSD size and type. Researchers will collect and analyze this data to track the heart defect's status. The study participation will last for at least 12 months to observe changes in the VSD size over time.

This research aims to compare the effects of adding batten grafts to the standard septoplasty and turbinate reduction surgeries for nasal obstruction caused by septal deviation and related issues. The study focuses on improving nasal airflow and reducing future surgeries by addressing not only septal deviation and inferior turbinate hypertrophy but also nasal valve collapse, which can contribute to breathing difficulties. Participants will be randomly assigned to one of two groups. In the intervention group, a piece of the patient's own nasal septal cartilage will be reshaped and re-implanted as a batten graft during septoplasty and turbinate reduction. The control group will receive the standard septoplasty and turbinate reduction without the batten graft. The study evaluates these approaches over a 12-month period, measuring nasal symptoms and airflow. During the trial, participants will undergo evaluations including symptom questionnaires and airflow measurements at 12 months after surgery. Researchers will monitor nasal obstruction symptoms, nasal valve function, peak inspiratory flow, any complications or side effects, cost-effectiveness, and the need for additional surgeries. The total participation time includes follow-up assessments over one year to assess long-term outcomes.

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.

Researchers are investigating how abnormal blood flow regulation in the brains of fetuses with complex congenital heart disease (CCHD) relates to delays in neurodevelopment. The study also looks at how this relationship is influenced by patient factors like the type of heart defect, maternal-fetal environment, and social determinants of health in a diverse group of pregnant women. This study uses data from multiple centers and approaches pregnant women during their fetal cardiology visits. The study involves a single treatment group where pregnant women receive maternal hyperoxia (MH) therapy at around 28 weeks gestation during their scheduled fetal echocardiogram. MH involves breathing 100% oxygen through a face mask for 10 minutes, with imaging taken before, during, and after this oxygen exposure to observe changes in the fetal brain's blood flow. Following birth, neonates with congenital heart disease undergo a pre-operative neurobehavioral assessment using the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS). Participants will have their fetal brain blood flow measured via ultrasound at baseline, during MH, and after recovery. After birth, the neurobehavioral scale will be administered by certified therapists to evaluate attention and related functions within 30 days of life. Researchers will collect detailed patient and environmental information to analyze how these factors affect brain blood flow and neurodevelopment. The total study period includes prenatal evaluation and neonatal assessment within the first month of life, with no additional visits required beyond routine care.

Researchers are evaluating the Occlutech4 muscular ventricular septal defect (mVSD) Occluder for patients who have significant muscular ventricular septal defects. This international, multicenter follow-up study aims to confirm the device's safety and effectiveness in closing these heart defects using a catheter-based, minimally invasive procedure. The study includes both prospective and retrospective patients and is sponsored by Occlutech International AB. The Occlutech mVSD Occluder is a self-expanding device made of nitinol wire mesh with polyester patches to support defect closure and tissue growth. Experienced doctors implant the device through a catheter in a specialized cardiac lab, using imaging techniques like echocardiography and fluoroscopy to guide placement. Participants receive treatment according to device instructions and clinical routine. Follow-up visits are scheduled at 1 to 48 hours after the procedure, 30 to 60 days, 6 months, 1 year, and up to 3 years. Participants undergo safety and effectiveness assessments including echocardiography, vital signs, lab tests, and ECGs during these follow-ups. Key safety outcomes include monitoring for serious device-related complications such as heart block, device embolization, or infections within one year. Effectiveness is measured by the successful closure of the defect assessed by echocardiography at one year. The study is open to patients from 3 months to 80 years old who meet eligibility criteria and can attend all scheduled visits.

This research aims to evaluate the safety and feasibility of performing simultaneous exercise stress cardiac magnetic resonance (CPET-CMR) and cardiopulmonary exercise testing in patients who have left bundle branch area pacemakers (LBBAP) programmed to an atrial sensing mode. The study focuses on measuring right and left ventricular function and exercise capacity at different LBBAP programming settings. It is a prospective pilot study designed to generate preliminary data on these heart functions during rest and low intensity exercise. The study involves a one-day assessment with up to 20 subjects who have dual chamber LBBAP devices showing anodal capture. Participants will be tested under three different pacing settings: no ventricular pacing to establish baseline heart function, non-selective or selective left bundle branch area pacing (ns/sLBBAP), and left bundle branch area pacing with anodal capture (aLBBAP). Before imaging, pacemaker interrogation and electrocardiogram (ECG) analyses will be performed to determine optimal programming parameters. During exercise, cardiac magnetic resonance imaging will be conducted with MRI-compatible monitoring systems. Throughout the study day, participants will undergo continuous pacemaker telemetry monitoring to detect any sensing issues during the CPET-CMR procedure. Researchers will measure pacemaker atrial sensing events and assess left and right ventricular ejection fractions at rest and during exercise. The total participation includes baseline device checks, exercise testing with imaging, and safety monitoring under medical supervision. The study will help understand the impact of different LBBAP settings on heart function and exercise capacity over this single study visit.

This research aims to study patients who have mechanical complications following an acute myocardial infarction, also known as a heart attack. These complications include conditions like ventricular free-wall rupture, ventricular pseudo-aneurysm, acute mitral regurgitation from papillary muscle rupture, and ventricular septal rupture. The study seeks to understand the outcomes of different treatments, including surgery, percutaneous (minimally invasive) procedures, and conservative care, in current medical practice. It builds upon a previous retrospective study by collecting more accurate and focused data prospectively to better reflect contemporary treatment results. Data will be collected prospectively from January 1, 2025, to December 31, 2027, across multiple cardiac surgery and cardiology departments. The study will include all patients diagnosed with post-infarction mechanical complications regardless of the treatment assigned. Treatments being evaluated include surgical repair methods such as sutured or sutureless techniques, and percutaneous approaches like device closure for ventricular septal rupture or mitral valve repair devices. There is also monitoring of patients receiving conservative (non-surgical) treatments. Approximately 800 patients are expected to be enrolled from at least 50 centers worldwide. Participants will have their demographic and clinical information, including diagnosis, key lab tests, diagnostic procedures, treatments received, complications, and hospital outcomes recorded. Follow-up will occur annually up to five years to assess quality of life, hospital readmissions, interventions, and long-term survival. The main outcome measured is in-hospital mortality up to 30 days after enrollment. Data accuracy and analysis will be managed centrally to ensure consistency, and patients will provide informed consent before participation.