BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES) (SOCRATES)

BoStOn SCientific Rhythm MAnagemenT 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 Overview

• Status: Recruiting
• Conditions: Cardiac Disease
• Intervention / Treatment: Device: Implant; Procedure: Electrophysiologic procedure

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.

• Study Type: Observational
• Enrollment (Estimated): 12500

Contacts and Locations

• Study Contact: Name: Maria Paz Lopez-Chicharro; Phone Number: 1-800-227-3422; Email: maria.lopez-chicharro@bsci.com
• Study Contact Backup: Name: Jens B Goetzke, Dipl.Ing.; Phone Number: 1-800-227-3422; Email: Jens.Goetzke@bsci.com

Study Locations

• Belgium
  • Jette, Belgium, 1090
    • Recruiting
    • Universitair Ziekenhuis Brussel
    • Contact: Carlo de Asmundis, Prof.
  • Yvoir, Belgium, 5530
    • Recruiting
    • CHU UCL Namur - Site Godinne
    • Contact: Dominique Blommaert, Prof.
• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V 4G5
      • Recruiting
      • Institut Universitaire de Cardiologie et de Pneumologie de Quebec
      • Contact: Jean-Francois Sarrazin, MD
• France
  • Brest, France, 29200
    • Recruiting
    • CHRU de Brest, Hôpital de la Cavale Blanche
    • Contact: Jacques Mansourati, Prof.
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHRU de Clermont-Ferrand
    • Contact: Romain Eschalier, MD
  • Lomme, France, 59462
    • Recruiting
    • Hopital Saint Philibert
    • Contact: Aymeric Menet, MD
  • Pau, France
    • Recruiting
    • CHG de Pau
    • Contact: Hugues Bader, MD
  • Saint-Etienne, France, 42055
    • Recruiting
    • CHU de Saint-Etienne
    • Contact: Antoine Da Costa, Prof.
• Germany
  • Berlin, Germany, 12687
    • Recruiting
    • Unfallkrankenhaus Berlin Marzahn
    • Contact: Corinna Lenz, MD
  • Bochum, Germany, 44791
    • Completed
    • Augusta Kranken Anstalt GmbH
• Greece
  • Athens, Greece, 17674
    • Recruiting
    • Onassis Cardiac Surgery Center
    • Contact: Michael Ephremidis, MD
  • Athens, Greece, 11527
    • Completed
    • General Hospital of Athens "G. Gennimatas"
• Ireland
  • Dublin, Ireland, D07 WKW8
    • Recruiting
    • Mater Private Hospital
    • Contact: Gabor Szeplaki, Prof.
• Israel
  • Ramat Gan, Israel, 52621
    • Recruiting
    • Sheba Medical Center
    • Contact: Roy Beinart, MD
  • Tel Aviv, Israel, 6423906
    • Recruiting
    • Tel Aviv Sourasky Medical Center
    • Contact: Raphael Rosso, Professor
  • Tel Aviv, Israel, 62431
    • Recruiting
    • Tel Aviv Sourask Medical Center
    • Contact: Raphael Rosso, Professor
• Italy
  • Modena, Italy, 41124
    • Recruiting
    • Policlinico di Modena
    • Contact: Giuseppe Boriani, Prof.
  • Roma, Italy, 00168
    • Recruiting
    • Policlinico Universitario Agostino Gemelli
    • Contact: Gemma Pelargonio, MD
  • Roma, Italy, 00169
    • Recruiting
    • Policlinico Casilino
    • Contact: Leonardo Calò, MD
  • Roma, Italy, 00186
    • Recruiting
    • Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina
    • Contact: Stefano Bianchi, MD
• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Clinico San Carlos
    • Contact: Nicasio Pérez Castellano, MD
  • San Cristóbal de La Laguna, Spain, 38320
    • Recruiting
    • Hospital Universitario de Canarias
    • Contact: Francisco Bosa Ojeda, MD
  • Santa Cruz de Tenerife, Spain, 38010
    • Recruiting
    • Hospital Nuestra Señora de La Candelaria
    • Contact: Luis A. Acosta, MD
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hospital Universitario Miguel Servet
    • Contact: Antonio Asso Abadía, MD
• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • Recruiting
    • St. Bartholomew's Hospital
    • Contact: Ross Hunter, Prof.
  • Manchester, United Kingdom, M13 9WL
    • Recruiting
    • Manchester Heart Center
    • Contact: Charles Pearman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Device: Implant; 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.; Procedure: Electrophysiologic procedure; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Director: Eszter Pais, MD, Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Investigative Techniques; Genetic Phenomena; Genetic Techniques; Genetic Variation; Protein Engineering; Genetic Engineering; Mutation; Mutagenesis; Mutagenesis, Insertional
• Other Study ID Numbers: SOCRATES - C2157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No