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 drugs 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 drugs levels and behavior in the body. The total participation will last until the day 15 follow-up after dosing.

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 studying whether adding AdiaVita, an umbilical cord blood-derived stem cell and exosome product, to glutathione therapy improves autism symptoms in children aged 3 to 12 better than glutathione alone. This 24-month study focuses on children with confirmed Autism Spectrum Disorder ASD and aims to assess changes in autism symptoms, safety, quality of life, and overall well-being. The study includes a randomized, crossover design with two treatment groups during the initial three months. Participants are randomly assigned to receive either glutathione alone or glutathione plus monthly intravenous AdiaVita infusions during the first three months. Both groups apply topical glutathione cream twice daily at home. After the initial phase, children in the glutathione-only group may cross over to receive AdiaVita infusions if safety checks at month 6 are satisfactory. The study tracks symptoms using the Autism Treatment Evaluation Checklist ATEC completed by parents and therapists or teachers over the two-year period. Throughout the study, participants attend regular clinic visits for physical exams, vital signs monitoring, blood tests, and adverse event reporting. Safety and side effects are closely monitored, with serious events receiving immediate attention. Families will complete ATEC assessments at multiple time points to measure changes in autism symptoms. Participation is voluntary, with costs covering the first phase and extension. Data are securely stored with privacy protections, and families may withdraw at any time.

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 Echocardiographys 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 softwares 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 collecting real-world data on patient outcomes to assess the success and performance of the Lifetech CeraFlex PFO Closure System, a device designed to close Patent Foramen Ovale PFO without surgery. This multicenter, prospective, observational study aims to provide valuable information on how well the device works in everyday medical practice. Participants will receive the CeraFlex PFO Closure System, which includes the CeraFlex PFO Occluder and the SteerEase Introducer. The study follows patients after the procedure, tracking their progress at discharge, and then at 1-3 months, 6 months, 12 months, and 24 months post-procedure. The enrollment period is expected to last about 18 months, with each participant followed for two years after device implantation. During the study, participants will undergo various assessments including monitoring for procedural success shortly after the procedure, checking for residual shunts at several follow-up points, and tracking stroke-related events, device deficiencies, serious adverse events, and deaths up to 24 months post-implantation. Data is collected electronically to ensure accurate tracking of patient outcomes over the entire study period.

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 2017745. 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.

This research aims to monitor fecal continence in autistic children aged 5 to 12 who have completed toilet training for enuresis and to evaluate the effectiveness of a caregiver-led multidisciplinary intervention for encopresis delivered via telehealth. The study focuses on children who continue to experience encopresis after achieving urine continence, assessing a behavioral treatment combined with over-the-counter glycerin suppository use compared to a parent education program. Participants who still have encopresis after resolving enuresis will be randomly assigned to either the caregiver-mediated intervention or the parent education group. The intervention includes daily virtual appointments with a behavior analyst over two weeks, involving scheduled toilet sits, positive reinforcement for bowel movements, and use of glycerin suppositories as needed. The parent education group receives guidance on promoting continence and data collection for bowel movements. All participants will also consult a pediatric gastroenterologist to ensure safety and address constipation. Throughout the study, caregivers will complete bowel movement tracking and questionnaires, and participate in interviews with a blinded investigator to monitor encopresis, other concerns, and adverse events. The main outcome is improvement measured by the Clinical Global Impression Improvement scale five weeks after starting the intervention. Caregiver strain and fecal continence data will also be evaluated. Informed consent is obtained from guardians, with participant assent when appropriate.