BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)
SOCRATES
1 other identifier
observational
12,500
10 countries
26
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Longer than P75 for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2021
CompletedStudy Start
First participant enrolled
March 31, 2021
CompletedFirst Posted
Study publicly available on registry
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
April 29, 2026
April 1, 2026
9.8 years
March 18, 2021
April 27, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
System-related complication free rate
Freedom from complications related to system
From Cardiac Rhythm Management (CRM) device implant on day 0 through follow-up up to 10 years; from electrophysiological (EP) procedure on day 0 through follow-up from 30 days up to 1 year
Rate of product related performance deficiencies per product or product group
Performance of product/product group at implant/procedure
CRM implant on day 0; EP procedure on day 0
Rate of product related performance deficiencies per product or product group
Performance of product/product group through the implanted duration
CRM implant on day 0 through the implanted duration up to 10 years
Study Arms (1)
BSC Product Use
Subject fulfilling one of the following conditions: 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 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.
Interventions
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.
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.
Eligibility Criteria
The subjects will be recruited from the general patient population of the participating centers who are * receiving diagnosis or treatment using a BSC product in scope of SOCRATES and * fulfilling all inclusion criteria and none of the exclusion criteria.
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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).
- Subject is receiving diagnosis or therapy by means of any product, that is not approved for commercial use at the time of implant/procedure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Universitair Ziekenhuis Brussel
Jette, 1090, Belgium
CHU UCL Namur - Site Godinne
Yvoir, 5530, Belgium
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, G1V 4G5, Canada
CHRU de Brest, Hôpital de la Cavale Blanche
Brest, 29200, France
CHRU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
Hopital Saint Philibert
Lomme, 59462, France
CHG de Pau
Pau, France
CHU de Saint-Etienne
Saint-Etienne, 42055, France
Unfallkrankenhaus Berlin Marzahn
Berlin, 12687, Germany
Augusta Kranken Anstalt GmbH
Bochum, 44791, Germany
General Hospital of Athens "G. Gennimatas"
Athens, 11527, Greece
Onassis Cardiac Surgery Center
Athens, 17674, Greece
Mater Private Hospital
Dublin, D07 WKW8, Ireland
Sheba Medical Center
Ramat Gan, 52621, Israel
Tel Aviv Sourask Medical Center
Tel Aviv, 62431, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Policlinico di Modena
Modena, 41124, Italy
Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Policlinico Casilino
Roma, 00169, Italy
Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina
Roma, 00186, Italy
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, 38320, Spain
Hospital Nuestra Señora de La Candelaria
Santa Cruz de Tenerife, 38010, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
St. Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
Manchester Heart Center
Manchester, M13 9WL, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eszter Pais, MD
Boston Scientific Corporation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 10 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2021
First Posted
April 1, 2021
Study Start
March 31, 2021
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2030
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share