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RECRUITING
NCT04823663

BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)

Sponsor: Boston Scientific Corporation

View on ClinicalTrials.gov

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.

Official title: BoStOn SCientific Rhythm MAnagemenT REgiStry

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

12500

Start Date

2021-03-31

Completion Date

2030-12-31

Last Updated

2026-03-23

Healthy Volunteers

No

Conditions

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.

Locations (26)

Universitair Ziekenhuis Brussel

Jette, Belgium

CHU UCL Namur - Site Godinne

Yvoir, Belgium

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Québec, Quebec, Canada

CHRU de Brest, Hôpital de la Cavale Blanche

Brest, France

CHRU de Clermont-Ferrand

Clermont-Ferrand, France

Hopital Saint Philibert

Lomme, France

CHG de Pau

Pau, France

CHU de Saint-Etienne

Saint-Etienne, France

Unfallkrankenhaus Berlin Marzahn

Berlin, Germany

Augusta Kranken Anstalt GmbH

Bochum, Germany

General Hospital of Athens "G. Gennimatas"

Athens, Greece

Onassis Cardiac Surgery Center

Athens, Greece

Mater Private Hospital

Dublin, Ireland

Sheba Medical Center

Ramat Gan, Israel

Tel Aviv Sourask Medical Center

Tel Aviv, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Policlinico di Modena

Modena, Italy

Policlinico Universitario Agostino Gemelli

Roma, Italy

Policlinico Casilino

Roma, Italy

Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina

Roma, Italy

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Spain

Hospital Nuestra Señora de La Candelaria

Santa Cruz de Tenerife, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

St. Bartholomew's Hospital

London, United Kingdom

Manchester Heart Center

Manchester, United Kingdom