Atrial Septal Defect (ASD)

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 evaluating the effects of DT402, a psychoactive drug, in adults diagnosed with Autism Spectrum Disorder (ASD). This Phase 2A open-label study will involve about twenty adults aged 18 to 65 years. The study aims to understand how a single dose of DT402 affects symptoms related to socialization and communication difficulties common in ASD. Participants will receive a single 200 mg dose of DT402, which works mainly by releasing certain brain chemicals such as serotonin, norepinephrine, and dopamine. The study is conducted at a single center without any placebo or blinding, focusing on observing the drug's effects after one administration. Throughout the study, participants will be monitored at several time points up to 24 hours after dosing and again on day 15. Researchers will assess changes in symptom severity using an 11-point rating scale and gather subjective feedback through a drug effects questionnaire. Blood samples will also be collected to analyze the drug's levels and behavior in the body. The total participation will last until the day 15 follow-up after dosing.

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 evaluating whether adding AdiaVita, a product derived from umbilical cord blood stem cells and exosomes, to glutathione therapy can better improve symptoms of Autism Spectrum Disorder (ASD) in children aged 3 to 12 compared to glutathione alone. The study is designed as a 24-month research trial involving about 100 children with confirmed ASD diagnoses. The main goal is to observe changes in autism symptoms using the Autism Treatment Evaluation Checklist (ATEC) at six months, with additional focus on safety, quality of life, and overall well-being. Participants are randomly assigned to one of two groups for the first three months: one group receives glutathione alone, and the other receives glutathione plus monthly intravenous infusions of AdiaVita. Both groups use topical glutathione cream twice daily at home. After three months, children initially receiving only glutathione may switch to the combined treatment if safety checks at six months are satisfactory. The study includes physical exams, blood tests, and monitoring for side effects throughout. During the trial, children will have regular clinic visits for assessments including physical exams, blood tests, and adverse event reporting. Autism symptoms are tracked by parents and therapists or teachers using the ATEC at multiple points over two years. Safety and tolerability are closely monitored with immediate attention to any serious adverse events. Participation is voluntary, with secure data handling and ongoing evaluation over the full 24-month period.

Researchers are evaluating an investigational artificial intelligence (AI) software designed to estimate the severity of ejection fraction (EF), which indicates how well the heart pumps blood. This prospective, multicenter, cluster-randomized controlled study compares EF severity categories determined by the AI software using continuous ECG waveform data to those measured by an FDA-cleared transthoracic echocardiogram (TTE). The study aims to provide a low-burden, cost-effective alternative for EF monitoring in heart failure and related heart conditions, especially where traditional imaging access is limited. Participants will use the FDA-cleared Peerbridge COR4 ECG Wearable Monitor, a patch device worn during daily activities, to collect ECG data. During a 15-minute resting session while seated upright, 5-minute ECG segments will be recorded and analyzed by the AI software to estimate EF severity based on the American Society of Echocardiography's scale. The study includes two subprotocols: one with 30 minutes of ECG recording including 15 minutes analyzed, and another allowing up to 7 days of device use with periodic sitting sessions. The EF severity from the AI software will be compared against results from echocardiography. Participants will be enrolled at multiple sites, providing paired data points consisting of simultaneous or near-simultaneous ECG recordings and echocardiograms. They will follow a standardized 15-minute seated session protocol using the wearable device, pressing an event button to mark the session start and end. Data collection includes medical histories, 12-lead ECGs, and device logs. The main outcome measures focus on agreement between the AI software's EF severity categories and those from echocardiography over an average of 9 months. Safety and compliance will be monitored throughout the study period.

Researchers are evaluating the safety of stopping anticoagulant therapy in patients with atrial fibrillation who have had surgical closure of the left atrial appendage (LAA). This procedure is often done during cardiac surgery to reduce the risk of stroke and blood clots, which may allow patients to avoid ongoing blood thinners that increase bleeding risk. The ATLAAC trial is designed as a phase 4 randomized study to compare continued versus discontinued anticoagulation in this group. Participants will have undergone cardiac surgery with LAA closure verified by a cardiac CT scan. Those with successful closure are randomly assigned to either stop taking oral anticoagulants (such as warfarin or direct oral anticoagulants) or to continue them for the trial duration. This allows the trial to assess the risk of ischemic stroke, peripheral arterial embolism, and major bleeding events between the two approaches. During the approximately four-year follow-up, participants will be monitored for stroke severity, transient ischemic attacks, mortality rates, minor bleeding, and other cardiovascular events. Quality of life and patient satisfaction with treatment will also be evaluated at baseline and yearly intervals. The trial involves regular assessments to ensure safety and to measure key health outcomes related to anticoagulation status after LAA closure.

Researchers are gathering real-world information on patient outcomes and evaluating the performance and success of the CeraFlex15 PFO Closure System, a device designed to close Patent Foramen Ovale (PFO) without surgery. This multicenter, prospective, observational study is open-label and post-market, aiming to understand how well this device works in everyday medical practice. Participants will receive the Lifetech CeraFlex PFO closure system, which includes the CeraFlex PFO Occluder and the SteerEase Introducer. The device is applied through a catheter-based procedure to close the PFO. After enrollment over about 18 months, each participant will be followed for 24 months after the procedure to monitor outcomes and device performance. Throughout the study, participants will have assessments at hospital discharge, then at 1 to 3 months, 6 months, 12 months, and 24 months post-procedure. Data on procedural success, residual shunt, stroke events, device issues, serious adverse events, and death will be collected and analyzed. An electronic data capture system will be used to securely collect study information.

Atrial Septal Defect (ASD) is a type of congenital heart defect that may be closed without open-heart surgery. Traditionally, ASD closure was done surgically, but less invasive options like percutaneous transcatheter occluder devices have become available. This research aims to collect real-world clinical data and confirm the long-term safety and performance of the Lifetech Cera153 ASD Occluder, a device used to close ASD without surgery. The study also seeks to identify any previously unknown side effects of this device. Participants in this study will have received the Lifetech Cera153 ASD Occluder between January 2020 and December 2023, following instructions for use. The study is single-armed and observational, planned under the Regulation (EU) 2017/745. Subjects will be followed up for two years after device implantation to track outcomes and safety. The enrollment period is expected to last about one year with a target of 139 participants. During the study, researchers will monitor procedural success six months after implantation and assess successful closure of the defect immediately after the procedure, at hospital discharge, and at 12 months. They will also track new onset arrhythmias requiring treatment, device or procedure-related adverse events and serious adverse events, as well as any deaths from the time of the procedure up to two years post-implantation. Participants must attend follow-up visits as part of the study, with all data collected and processed with their consent.

This research aims to study cerebral microembolization in patients undergoing transcatheter closure of patent foramen ovale (PFO) or atrial septal defect (ASD). It also investigates the link between new cerebral microembolization and in situ blood clots within the PFO. PFO is common and linked to conditions like ischemic stroke, transient ischemic attack, migraines, and embolization, with clot formation possibly playing a role in related stroke or migraine cases. Participants will receive transcatheter closure using PFO or ASD occluder devices. Before closure, brain diffusion-weighted MRI (DW-MRI) scans will be done, with additional DW-MRI scans at 24 hours and one month after the procedure. During PFO closure, right atrial angiography and optical coherence tomography (OCT) will assess the PFO structure and detect any clots while the patient performs the Valsalva maneuver. Throughout the study, patients will undergo brain imaging before and after closure to monitor cerebral microembolization and thrombus presence. Researchers will measure new cerebral microembolization occurring from 24 hours to 4 weeks after closure. The study includes detailed imaging and clot evaluations to better understand microembolization risks and outcomes following PFO or ASD closure, with participation lasting through at least one month post-procedure.

Researchers are examining differences in neural cadherin (NCAD) levels and brain function between preschool children with autism spectrum disorder (ASD) and typically developing (TD) children. The study focuses on NCAD, a protein related to synaptic function, and uses functional near-infrared spectroscopy (fNIRS) to explore brain activity in resting and social interaction states. The goal is to understand how brain function characteristics relate to cognitive development in children with ASD. Children aged 3 to under 5 years with ASD or typical development are enrolled. Blood samples are collected to measure plasma NCAD concentration, and brain activity is recorded using fNIRS while children are at rest and during the Gesell developmental assessment. The TD group is matched to the ASD group by age and gender, ensuring normal developmental levels. Participants undergo physical measurements, blood and nutrient tests, neuropsychological assessments, and fNIRS imaging. Caregivers complete demographic questionnaires, and clinical data are verified from medical records. The study measures NCAD levels and brain function at baseline, analyzing data for correlations with developmental quotients. Ethical approval and informed consent are secured, with privacy protections in place. The study aims to include 49 children in each group and monitors data quality and safety throughout.