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BoStOn SCientific Rhythm Management-register (SOCRATES) (SOCRATES)

30 oktober 2026 bijgewerkt door: Boston Scientific Corporation

BoStOn SCientific Rhythm Management-register

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

12500

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: OTHER

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
System-related complication free rate
Tijdsspanne: 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

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
Tijdsspanne: CRM implant on day 0; EP procedure on day 0

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
Tijdsspanne: CRM implant on day 0 through the implanted duration up to 10 years

Performance of product/product group through the implanted duration
CRM implant on day 0 through the implanted duration up to 10 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Boston Scientific Corporation

Onderzoekers

  • Studie directeur: Eszter Pais, MD, Boston Scientific Corporation

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

31 maart 2021

Primaire voltooiing (Geschat)

31 december 2030

Studie voltooiing (Geschat)

31 december 2030

Studieregistratiedata

Eerst ingediend

18 maart 2021

Eerst ingediend dat voldeed aan de QC-criteria

26 maart 2021

Eerst geplaatst (Werkelijk)

1 april 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 november 2026

Laatste update ingediend die voldeed aan QC-criteria

30 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SOCRATES - C2157

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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