Actively Recruiting

All Genders
NCT04823663

BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)

Led by Boston Scientific Corporation · Updated on 2026-04-29

12500

Participants Needed

26

Research Sites

508 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subject is willing and able to provide informed consent or approval for personal health information collection, or consent is provided by a legally authorized representative if required by local law.
  • Subject is prospectively scheduled for a procedure involving use of a Boston Scientific electrophysiology ablation product, capital equipment product, or a Boston Scientific cardiac rhythm management device implant.
  • Subject may be retrospectively enrolled no more than 10 days after the index procedure if all necessary data for past visits is available and complete, including diagnosis or treatment with at least 3 separate Boston Scientific electrophysiology ablation or capital equipment products or a Boston Scientific cardiac rhythm management device implant.
Not Eligible

You will not qualify if you...

  • Subject is not expected to be followed at the enrolling center for at least 1 year after a cardiac rhythm management implant procedure or at least 1 month after an electrophysiology procedure.
  • Subject is receiving diagnosis or therapy using any product not approved for commercial use at the time of implant or procedure.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 26 locations

1

Universitair Ziekenhuis Brussel

Jette, Belgium, 1090

Actively Recruiting

2

CHU UCL Namur - Site Godinne

Yvoir, Belgium, 5530

Actively Recruiting

3

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Québec, Quebec, Canada, G1V 4G5

Actively Recruiting

4

CHRU de Brest, Hôpital de la Cavale Blanche

Brest, France, 29200

Actively Recruiting

5

CHRU de Clermont-Ferrand

Clermont-Ferrand, France, 63000

Actively Recruiting

6

Hopital Saint Philibert

Lomme, France, 59462

Actively Recruiting

7

CHG de Pau

Pau, France

Actively Recruiting

8

CHU de Saint-Etienne

Saint-Etienne, France, 42055

Actively Recruiting

9

Unfallkrankenhaus Berlin Marzahn

Berlin, Germany, 12687

Actively Recruiting

10

Augusta Kranken Anstalt GmbH

Bochum, Germany, 44791

Completed

11

General Hospital of Athens "G. Gennimatas"

Athens, Greece, 11527

Completed

12

Onassis Cardiac Surgery Center

Athens, Greece, 17674

Actively Recruiting

13

Mater Private Hospital

Dublin, Ireland, D07 WKW8

Actively Recruiting

14

Sheba Medical Center

Ramat Gan, Israel, 52621

Actively Recruiting

15

Tel Aviv Sourask Medical Center

Tel Aviv, Israel, 62431

Actively Recruiting

16

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 6423906

Actively Recruiting

17

Policlinico di Modena

Modena, Italy, 41124

Actively Recruiting

18

Policlinico Universitario Agostino Gemelli

Roma, Italy, 00168

Actively Recruiting

19

Policlinico Casilino

Roma, Italy, 00169

Actively Recruiting

20

Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina

Roma, Italy, 00186

Actively Recruiting

21

Hospital Clinico San Carlos

Madrid, Spain, 28040

Actively Recruiting

22

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Spain, 38320

Actively Recruiting

23

Hospital Nuestra Señora de La Candelaria

Santa Cruz de Tenerife, Spain, 38010

Actively Recruiting

24

Hospital Universitario Miguel Servet

Zaragoza, Spain, 50009

Actively Recruiting

25

St. Bartholomew's Hospital

London, United Kingdom, EC1A 7BE

Actively Recruiting

26

Manchester Heart Center

Manchester, United Kingdom, M13 9WL

Actively Recruiting

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Research Team

M

Maria Paz Lopez-Chicharro

CONTACT

J

Jens B Goetzke, Dipl.Ing.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES) | DecenTrialz