BoStOn SCientific Rhythm MAnagemenT REgiStry
- Cardiac Disease
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Boston Scientific Corporation
- Enrolment target
- 12,500
- Started
- 31 March 2021
- Main results due
- 31 December 2030
- Study sites
- 26
- Registry updated
- 25 September 2026
Can you take part?
- No age limit is stated.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(26)
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, Canada
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
Showing 26 of 26 sites. 24 of the 26 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT04823663. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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