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NCT04823663From ClinicalTrials.govRecruiting

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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