Abbott Structural Heart Device Registry

What this Trial Is About

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.

Abbott Structural Heart Device Registry