Boston Scientific Rhythm Management Registry SOCRATES for Cardiac Device and Procedure Monitoring

What this Trial Is About

The SOCRATES study is a global, non-randomized, observational registry designed to collect post-market data on the quality, performance, and safety of Boston Scientific devices used for cardiac rhythm management and electrophysiology procedures. It supports regulatory requirements such as the European Medical Device Regulation by systematically gathering relevant device data over their entire lifetime. The study includes both prospective enrollment and a limited retrospective enrollment window of up to 10 days after the procedure. Participants in SOCRATES undergo procedures involving Boston Scientific EP Ablation, Capital Equipment, or Cardiac Rhythm Management CRM products as part of their standard care. The registry collects data on device use, including combinations with competitor products, and follows subjects for variable durations depending on the device lifetime or safety assessment needs. For CRM devices, follow-up can extend up to 10 years, while electrophysiological procedures are followed from 7 days to one year post-procedure. Re-enrollment is possible when local regulations require extended follow-up. During the study, data on device performance and complications are gathered from routine clinical care visits. Researchers assess system-related complication-free rates, product-related performance deficiencies, and long-term safety outcomes. Participants are observed through their usual healthcare visits without intervention from the study team. The study is ongoing without a predefined end date, allowing continuous enrollment to meet regulatory post-market surveillance needs.

BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)