Clinical Trial

BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)

Study acronym: SOCRATES
Recruiting
View on ClinicalTrials.gov →
Summary
SOCRATES is part of Boston Scientific's (BSC) Post-market surveillance system. The implementation of such systems is mandatory per local regulations such as the Regulation '(EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices' or short Medical Device Regulation (MDR). The SOCRATES design is therefore based on the BSC's commitment as well as external regulatory requirements to proactively and systematically gather, record and analyze relevant data on the quality, performance and safety of devices throughout their entire lifetime.
Protocol Amendment History 63 amendments
This ClinicalTrials.gov record has been amended 63 times since 2021-03-26; most recent amendment 2026-07-23.
Status change: Not Yet Recruiting → Recruiting 2021-04-06
Trial Details
NCT Number NCT04823663
Lead Sponsor Boston Scientific Corporation
Conditions Cardiac Disease
Enrollment 12,500 participants
Start Date 2021-03-31
Primary Completion 2030-12-31 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-24