BoStOn SCientific Rhythm MAnagemenT REgiStry

NCT04823663 · tracked via the Priya Life Science UK tracker

Sponsor

Boston Scientific Corporation

Phase

Observational

Started

2021-03-31

Last updated

2026-08-24

Condition(s) studied

Cardiac Disease

Investigational drug(s) / intervention(s)

ImplantElectrophysiologic procedure

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.

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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

System-related complication free rate — 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
Freedom from complications related to system
Rate of product related performance deficiencies per product or product group — CRM implant on day 0; EP procedure on day 0
Performance of product/product group at implant/procedure
Rate of product related performance deficiencies per product or product group — CRM implant on day 0 through the implanted duration up to 10 years
Performance of product/product group through the implanted duration

Trial sites (26)

Facility	City	Region	Status
Universitair Ziekenhuis Brussel	Jette	Belgium	Recruiting
CHU UCL Namur - Site Godinne	Yvoir	Belgium	Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Quebec	Québec	Quebec	Recruiting
CHRU de Brest, Hôpital de la Cavale Blanche	Brest	France	Recruiting
CHRU de Clermont-Ferrand	Clermont-Ferrand	France	Recruiting
Hopital Saint Philibert	Lomme	France	Recruiting
CHG de Pau	Pau	France	Recruiting
CHU de Saint-Etienne	Saint-Etienne	France	Recruiting
Unfallkrankenhaus Berlin Marzahn	Berlin	Germany	Recruiting
Augusta Kranken Anstalt GmbH	Bochum	Germany	Completed
General Hospital of Athens "G. Gennimatas"	Athens	Greece	Completed
Onassis Cardiac Surgery Center	Athens	Greece	Recruiting
Mater Private Hospital	Dublin	Ireland	Recruiting
Sheba Medical Center	Ramat Gan	Israel	Recruiting
Tel Aviv Sourask Medical Center	Tel Aviv	Israel	Recruiting
Tel Aviv Sourasky Medical Center	Tel Aviv	Israel	Recruiting
Policlinico di Modena	Modena	Italy	Recruiting
Policlinico Universitario Agostino Gemelli	Roma	Italy	Recruiting
Policlinico Casilino	Roma	Italy	Recruiting
Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina	Roma	Italy	Recruiting
Hospital Clinico San Carlos	Madrid	Spain	Recruiting
Hospital Universitario de Canarias	San Cristóbal de La Laguna	Spain	Recruiting
Hospital Nuestra Señora de La Candelaria	Santa Cruz de Tenerife	Spain	Recruiting
Hospital Universitario Miguel Servet	Zaragoza	Spain	Recruiting
St. Bartholomew's Hospital	London	United Kingdom	Recruiting
Manchester Heart Center	Manchester	United Kingdom	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04823663 on ClinicalTrials.gov ↗ ← All trials in the UK