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 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.

The Abbott Structural Heart SH Registry is designed to confirm the safety and performance of Abbotts commercially available structural heart devices in real-world clinical settings. It collects data from routine hospital practices and standard-of-care procedures involving patients with various heart conditions such as atrial septal defect, ventricular septal defect, patent foramen ovale, and valvular heart disease. The study aims to meet regulatory requirements, including those from the European Union Medical Device Regulations 2017745, by conducting active post-market clinical follow-up for these devices. Participants in this observational registry receive structural heart devices like the Amplatzer Occlusion Devices for septal defects or the Epic Surgical Tissue Heart Valve devices for valve replacement as part of their standard care. Enrollment occurs either before the procedure or shortly afterward, depending on the device type. Follow-up visits align with routine care schedules and may be in-person, virtual, or by phone. Follow-up duration varies by device, ranging from discharge or 7 days post-procedure up to 10 years to monitor long-term performance and safety. A specific surgical valve sub-study is included to gather data for regulatory approval of certain valve sizes. Participants provide informed consent and are followed through standard care visits where data is collected about safety and effectiveness outcomes. The registry tracks primary safety endpoints at 7 days post-procedure and effectiveness at baseline. Follow-up assessments may include in-office or remote visits and data collection over months to years depending on the device implanted. The total participation duration depends on the device but can extend up to a decade, ensuring long-term monitoring of device performance in everyday clinical practice.

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 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 patients 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 monitoring the safety and effectiveness of the Occlutech muscular ventricular septal defect mVSD Occluder in patients with muscular ventricular septal defects. This international follow-up study includes both prospective and retrospective data collection to confirm how well the device closes muscular ventricular septal defects and to assess any serious adverse effects related to its use. The study is sponsored by Occlutech International AB and aims to enroll up to 50 patients. Participants receive the Occlutech mVSD Occluder through a minimally invasive catheter-based procedure performed by experienced cardiologists in specialized facilities. The device is a self-expandable wire-mesh occluder designed to close the defect and support tissue growth. Patients are treated according to device instructions and usual clinical practice. Follow-up visits occur at intervals including within 48 hours post-procedure, 1 to 2 months, 6 months, 1 year, and up to 3 years after implantation. During the study, participants undergo echocardiography, vital signs monitoring, lab tests, and ECGs to assess device performance and safety. Researchers measure the rate of serious device-related adverse events within 12 months and successful defect closure at 1 year. Additional monitoring continues up to 3 years for minor complications and late safety outcomes. Participants are expected to attend scheduled follow-up visits and assessments throughout the study period.

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.

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.

This research aims to evaluate the effectiveness of a machine-learning ML model in predicting serious cardiac events within three months among pediatric cardiac inpatients. The study focuses on determining whether the ML model increases palliative care team PACT consultations, reduces time to consultation, decreases ICU deaths, and improves documentation of care goals. The study is conducted at The Hospital for Sick Children, leveraging their strong collaboration between cardiology and palliative care. The ML model identifies high-risk cardiology patients daily. If a patient was seen by PACT in the past year, the update goes to the PACT team otherwise, the cardiology physician in charge receives the alert to decide on consultation. The study compares patient outcomes before and after deploying the ML model, with a pre-deployment period covering 12 months starting 15 months before deployment, and a post-deployment period covering 12 months beginning 3 months after deployment. Participants are pediatric cardiology inpatients. Researchers will monitor PACT consultations within three months of admission, time to consultation, ICU death rates, and documentation of care goals. Outcomes among identified high-risk patients will be compared between the pre- and post-deployment periods to assess the ML models impact on care processes and patient outcomes.