RecruitingNot Applicable

BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)

Belgium, Canada, France12,500 participantsStarted 2021-03-31

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

System-related complication free rate

Timeframe: From Cardiac Rhythm Management (CRM) device implant on day 0 through follow-up up to 10 years; from electrophysiological (EP) procedure on day 0 through follow-up from 30 days up to 1 year

Rate of product related performance deficiencies per product or product group

Timeframe: CRM implant on day 0; EP procedure on day 0

Rate of product related performance deficiencies per product or product group

Timeframe: CRM implant on day 0 through the implanted duration up to 10 years

Trial details

NCT IDNCT04823663

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2030-12-31

Contact for this trial

Maria Paz Lopez-Chicharro

1-800-227-3422 maria.lopez-chicharro@bsci.com

View on ClinicalTrials.gov More Cardiac Disease trials

Plain-language summary

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

System-related complication free rate

Timeframe: From Cardiac Rhythm Management (CRM) device implant on day 0 through follow-up up to 10 years; from electrophysiological (EP) procedure on day 0 through follow-up from 30 days up to 1 year

Rate of product related performance deficiencies per product or product group

Timeframe: CRM implant on day 0; EP procedure on day 0

Rate of product related performance deficiencies per product or product group

Timeframe: CRM implant on day 0 through the implanted duration up to 10 years