Status:
RECRUITING
BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Cardiac Disease
Eligibility:
All Genders
Brief 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 Europe...
Detailed Description
SOCRATES is a non-randomized, multisite, single-arm, open-label, global post-market observational data collection per standard of care. While generally of prospective design, a limited retrospective e...
Eligibility Criteria
Inclusion
- Subject is willing and capable of providing informed consent and/or to give approval to collect/store/process personal health information by the sponsor or such consent/approval is provided by a legally designated representative, if required by local law or regulation.
- Subject is (one criterion must be fulfilled) a. prospectively scheduled for a procedure involving i. use of a BSC EP Ablation product or BSC Capital Equipment product or ii. a BSC CRM product implant or b. retrospectively enrolled no more than 10 days after the index procedure and all data necessary for appropriate reporting of all past visits is available and complete including i. the procedure where being diagnosed or treated with at least 3 separate BSC EP Ablation products/components or BSC Capital Equipment products/components or ii. the BSC CRM product implant.
Exclusion
- Subject is foreseen not to be followed at the enrolling center for at least 1 year after an implant procedure (CRM) or at least 1 month (EP).
- Subject is receiving diagnosis or therapy by means of any product, that is not approved for commercial use at the time of implant/procedure.
Key Trial Info
Start Date :
March 31 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
12500 Patients enrolled
Trial Details
Trial ID
NCT04823663
Start Date
March 31 2021
End Date
December 31 2030
Last Update
January 5 2026
Active Locations (25)
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1
Universitair Ziekenhuis Brussel
Jette, Belgium, 1090
2
CHU UCL Namur - Site Godinne
Yvoir, Belgium, 5530
3
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, Canada, G1V 4G5
4
CHRU de Brest, Hôpital de la Cavale Blanche
Brest, France, 29200