SH-RegistrySafety and Performance of Abbott Structural Heart Devices

The Abbott Structural Heart Device Registry is a study focused on understanding how well Abbott's heart devices perform and how safe they are when used in everyday hospital settings. This study involves patients who are receiving these devices as part of their standard medical care. It aims to include around 500 participants each year over a minimum of five years. This research is critical because it helps ensure that these devices, used in heart procedures, work effectively and safely for patients around the world. By doing so, the study aims to improve heart treatment options and outcomes for patients who need these devices. Participants in this study will have their data collected after they consent and undergo a procedure involving an Abbott heart device. The study tracks how well the procedures go by measuring the number of successful device implants and monitors potential safety concerns by noting any serious health issues related to the device or procedure within a week afterward. Follow-up visits are scheduled based on the type of device used, ranging from a few months to up to ten years in some cases. These visits can happen in person, over the phone, or virtually, depending on what is standard for the patient's hospital. Additionally, data from European sites are collected to support approval for specific heart valve sizes in the U.S.