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REGISTRE SCIENTIFIQUE DE LA GESTION DU RHYTHME DE BOSTON (SOCRATES) (SOCRATES)

30 octobre 2026 mis à jour par: Boston Scientific Corporation

REGISTRE DE GESTION DU RHYTHME SCIENTIFIQUE DE BOSTON

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

12500

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: OTHER

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Dispositif: 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.

Procédure: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
System-related complication free rate
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Boston Scientific Corporation

Les enquêteurs

  • Directeur d'études: Eszter Pais, MD, Boston Scientific Corporation

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

31 mars 2021

Achèvement primaire (Estimé)

31 décembre 2030

Achèvement de l'étude (Estimé)

31 décembre 2030

Dates d'inscription aux études

Première soumission

18 mars 2021

Première soumission répondant aux critères de contrôle qualité

26 mars 2021

Première publication (Réel)

1 avril 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SOCRATES - C2157

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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