Recruiting

Observational Study

Sponsor:

Boston Scientific Corporation

Code:

NCT04823663

Conditions

Cardiac Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Implant

Electrophysiologic procedure

Study Details

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 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

Study ID

NCT04823663

Start date

Mar 31, 2021

Status verified date

Aug, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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.
2. 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:

1. 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).
2. Subject is receiving diagnosis or therapy by means of any product, that is not approved for commercial use at the time of implant/procedure.

Study Design

Enrollment

12500 participants

Anticipated

Interventions and Outcome Measures

Arms

BSC Product Use

Subject fulfilling one of the following conditions:

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 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.

Interventions

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.

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.

Primary outcome measure

  • System-related complication free rate [ Time Frame: 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 [ Time Frame: CRM implant on day 0; EP procedure on day 0 ]
  • Rate of product related performance deficiencies per product or product group [ Time Frame: CRM implant on day 0 through the implanted duration up to 10 years ]

Central Contacts and Locations

Central contacts

Maria Paz Lopez-Chicharro

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

Jens B Goetzke, Dipl.Ing.

1-800-227-3422Jens.Goetzke@bsci.com

Locations

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Recruiting

Québec, Quebec, Canada, G1V 4G5

More Information

Sponsor

Boston Scientific Corporation

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Scientific Corporation on 2026-08-24.