Bad Rothenfelde

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.

This registry observes patients with heart valve disease who have undergone or are planned to undergo surgical heart valve repair or replacement. The purpose is to support ongoing post-market surveillance of these devices by monitoring their performance and safety over time. Participants receive surgical heart valve repair or replacement products as part of their standard care. This study collects information about patients treated with these devices, either prospectively at the time of surgery or retrospectively if treated earlier. The registry follows patients long-term to identify any unique failure modes or adverse device effects. During the study, patients are monitored for up to 10 years to assess device performance and safety trends. Researchers collect data through follow-up visits and medical records to track outcomes related to the surgical valve products. The study helps improve understanding of device durability and safety in real-world patient use.

Spontaneous coronary artery dissection SCAD is a recognized cause of non-atherosclerotic acute coronary syndromes, mainly affecting young women without typical risk factors. Researchers are building the first pan-European SCAD registry to improve understanding of this conditions diagnosis and management, inform guidelines, educate clinicians, and promote research. This international, multicenter, observational study includes both retrospective and prospective patient data. The study collects data without any treatment interventions, enrolling at least 500 new patients and 500 historical cases from about 30 countries and 120 sites. Patient information is gathered from their first SCAD event, at enrollment, and then yearly for up to five years or until study completion. There are no study drugs or procedures involved as it is purely observational. Participants will provide data at multiple time points including baseline and yearly follow-ups for up to five years. Researchers will review patient status, vital signs, recurrent SCAD events, imaging results, medications, menstrual and obstetric history, and discharge details. Additional information on procedures, other coronary events, symptoms, pregnancy and hormonal therapy, exercise habits, mental health, and employment after SCAD will also be collected. This allows a comprehensive understanding of SCAD over time.