BoStOn SCientific Rhythm MAnagemenT REgiStry

What this Trial Is About

Researchers are conducting the SOCRATES registry as part of Boston Scientific's commitment and regulatory requirements to monitor the quality, performance, and safety of their cardiac rhythm management (CRM) and electrophysiology (EP) devices throughout their entire lifetime. This ongoing, global, observational study collects data from patients using these devices under routine medical care, with no set end date, to support post-market clinical follow-up in compliance with medical device regulations. Participants include individuals scheduled for procedures involving Boston Scientific CRM device implants or EP ablation and capital equipment products, as well as those enrolled retrospectively within 10 days after such procedures. Data collection follows standard care practices and includes the use of Boston Scientific devices alone or in combination with competitor products. The study allows continuous enrollment with no upper limit on participant numbers and monitors device performance and complications over varying durations, from days to years depending on device type and regulatory needs. During participation, patients' health information and device-related data are collected and analyzed to assess system-related complication rates and product performance deficiencies, including follow-up periods up to 10 years for CRM implants. The study tracks these outcomes through standard clinical visits and procedures, ensuring data continuity even if participants are re-enrolled. This comprehensive monitoring helps fulfill regulatory requirements and enhances understanding of device safety and effectiveness over time.

BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)