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BoStOn SCientific Rhythm MAnagemenT REgiStry

NCT04823663 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 12500

Last updated 2026-08-24

No results posted yet for this study

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.

Conditions

  • Cardiac Disease

Interventions

DEVICE

Implant

In the scope of the CRM procedure and subsequent follow-up, the registry will provide information on the use of the Boston Scientific CRM products/components and combination of those products/components with competitor product(s) per hospital's standard of care.

PROCEDURE

Electrophysiologic procedure

In the scope of the EP procedure and subsequent follow-up, the registry will provide information on the use of the Boston Scientific Electrophysiology products/components and capital equipment products and combination of those products/components with competitor product(s) per hospital's standard of care.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Eszter Pais, MD · Boston Scientific Corporation

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • Belgium
  • Canada
  • France
  • Germany
  • Greece
  • Ireland
  • Israel
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04823663 on ClinicalTrials.gov