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BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)
Sponsor: Boston Scientific Corporation
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
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.
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