Abbott Structural Heart Device Registry Monitoring Safety and Performance of Abbott Heart Devices in Real-World Hospital Use

What this Trial Is About

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.

Abbott Structural Heart Device Registry