Cardiac DiseaseSOCRATESNCT04823663
BoStOn SCientific Rhythm MAnagemenT REgiStry
An observational study of Cardiac Disease, run by Boston Scientific Corporation at 26 sites in 10 countries.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Implant and Electrophysiologic procedure
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 12,500 participants
- Where
- 26 sitesin 10 countries
- Study dates
- 31 Mar 2021to 31 Dec 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
26 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 10 countries
France5 sites, 5 recruiting
- Recruiting
CHRU de Brest, Hôpital de la Cavale Blanche
Brest, 29200
Jacques Mansourati, Prof.
- Recruiting
CHRU de Clermont-Ferrand
Clermont-Ferrand, 63000
Romain Eschalier, MD
- Recruiting
Hopital Saint Philibert
Lomme, 59462
Aymeric Menet, MD
- Recruiting
CHG de Pau
Pau
Hugues Bader, MD
- Recruiting
CHU de Saint-Etienne
Saint-Etienne, 42055
Antoine Da Costa, Prof.
Italy4 sites, 4 recruiting
- Recruiting
Policlinico di Modena
Modena, 41124
Giuseppe Boriani, Prof.
- Recruiting
Policlinico Universitario Agostino Gemelli
Roma, 00168
Gemma Pelargonio, MD
- Recruiting
Policlinico Casilino
Roma, 00169
Leonardo Calò, MD
- Recruiting
Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina
Roma, 00186
Stefano Bianchi, MD
Spain4 sites, 4 recruiting
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
Nicasio Pérez Castellano, MD
- Recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna, 38320
Francisco Bosa Ojeda, MD
- Recruiting
Hospital Nuestra Señora de La Candelaria
Santa Cruz de Tenerife, 38010
Luis A. Acosta, MD
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
Antonio Asso Abadía, MD
Israel3 sites, 3 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, 52621
Roy Beinart, MD
- Recruiting
Tel Aviv Sourask Medical Center
Tel Aviv, 62431
Raphael Rosso, Professor
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Raphael Rosso, Professor
Belgium2 sites, 2 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Jette, 1090
Carlo de Asmundis, Prof.
- Recruiting
CHU UCL Namur - Site Godinne
Yvoir, 5530
Dominique Blommaert, Prof.
Germany2 sites, 1 recruiting
- Recruiting
Unfallkrankenhaus Berlin Marzahn
Berlin, 12687
Corinna Lenz, MD
- Completed
Augusta Kranken Anstalt GmbH
Bochum, 44791
Greece2 sites, 1 recruiting
- Completed
General Hospital of Athens "G. Gennimatas"
Athens, 11527
- Recruiting
Onassis Cardiac Surgery Center
Athens, 17674
Michael Ephremidis, MD
United Kingdom2 sites, 2 recruiting
- Recruiting
St. Bartholomew's Hospital
London, EC1A 7BE
Ross Hunter, Prof.
- Recruiting
Manchester Heart Center
Manchester, M13 9WL
Charles Pearman, MD
Canada1 site, 1 recruiting
- Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, G1V 4G5
Jean-Francois Sarrazin, MD
Ireland1 site, 1 recruiting
- Recruiting
Mater Private Hospital
Dublin, D07 WKW8
Gabor Szeplaki, Prof.
About this study
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.
Read the detailed description
SOCRATES is a non-randomized, multisite, single-arm, open-label, global post-market observational data collection per standard of care. While generally of prospective design, a limited retrospective element is allowed for the inclusion of patients for a short period of 10 days after their index procedure.
SOCRATES intends to enroll a number of subjects that will support the analysis of all the individual Post Market Clinical Follow-Up (PMCF) Plans. An average of approximately 100 subjects per year and site on a continuous basis is expected but may vary depending on the needs of individual PMCF Plans. As long as SOCRATES is active, there is no upper limit to the total number of subjects that may be enrolled, and enrollment will be driven by the need to support sample sizes of individual PMCF plans for given products/product groupings supported by SOCRATES.
SOCRATES is designed to be a continuous effort after the data collection commences without a predefined closure timepoint. Data collection and enrollment may be stopped, restarted or finalized per Sponsor discretion.
The expected duration of SOCRATES participation for a subject is dependent on
- the specific lifetime of the device (e.g. the battery usage for pulse generators or continued active use of leads for CRM devices) or
- the necessary timeframe to adequately assess safety and performance of the device based on the residual risk assessed for each device in the associated PMCF plan. Timeframes might e.g. spread from 7 days to one year post procedure for EP. The maximum duration per enrolled subject will consequently vary.
For BSC implantable devices subjects are intended to be followed for the entire time of being implanted with a BSC device to allow data collection over the lifetime of the device(s) as required by applicable regulations. A maximum duration per enrolled subject is not defined, unless locally required. In case a local maximum duration is enforced subjects may be consented again and re-enrolled for continued participation if they are still in scope for SOCRATES. Sites shall ensure continuous data collection without any gaps in case a re-enrollment becomes applicable. Data sets for re-enrolled subjects will be handled as if the subject was continuously enrolled. This process will ensure to meet the requirement of MDR for device manufacturers to collect data over the lifetime of the devices.
- Conditions
- Cardiac Disease
- Being tested
- Implant, Electrophysiologic procedure
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImplantDevice
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 procedureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Implant; Procedure: Electrophysiologic procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
System-related complication free rate
Freedom from complications related to system
Measured: 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
Measured: 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
Measured: CRM implant on day 0 through the implanted duration up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start31 Mar 2021
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 12,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eszter Pais, MD, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823663
- Sponsor's protocol ID
- SOCRATES - C2157
- Acronym
- SOCRATES
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2021
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No