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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Maria Paz Lopez-Chicharro
- Telefonnummer: 1-800-227-3422
- E-post: maria.lopez-chicharro@bsci.com
Studer Kontakt Backup
- Navn: Jens B Goetzke, Dipl.Ing.
- Telefonnummer: 1-800-227-3422
- E-post: Jens.Goetzke@bsci.com
Studiesteder
-
-
-
Jette, Belgia, 1090
- Rekruttering
- Universitair Ziekenhuis Brussel
-
Ta kontakt med:
- Carlo de Asmundis, Prof.
-
Yvoir, Belgia, 5530
- Rekruttering
- CHU UCL Namur - Site Godinne
-
Ta kontakt med:
- Dominique Blommaert, Prof.
-
-
-
-
Quebec
-
Québec, Quebec, Canada, G1V 4G5
- Rekruttering
- Institut Universitaire de Cardiologie et de Pneumologie de Quebec
-
Ta kontakt med:
- Jean-Francois Sarrazin, MD
-
-
-
-
-
Brest, Frankrike, 29200
- Rekruttering
- CHRU de Brest, Hôpital de la Cavale Blanche
-
Ta kontakt med:
- Jacques Mansourati, Prof.
-
Clermont-Ferrand, Frankrike, 63000
- Rekruttering
- CHRU de Clermont-Ferrand
-
Ta kontakt med:
- Romain Eschalier, MD
-
Lomme, Frankrike, 59462
- Rekruttering
- Hopital Saint Philibert
-
Ta kontakt med:
- Aymeric Menet, MD
-
Pau, Frankrike
- Rekruttering
- CHG de Pau
-
Ta kontakt med:
- Hugues Bader, MD
-
Saint-Etienne, Frankrike, 42055
- Rekruttering
- CHU de Saint-Etienne
-
Ta kontakt med:
- Antoine Da Costa, Prof.
-
-
-
-
-
Athens, Hellas, 17674
- Rekruttering
- Onassis Cardiac Surgery Center
-
Ta kontakt med:
- Michael Ephremidis, MD
-
Athens, Hellas, 11527
- Fullført
- General Hospital of Athens "G. Gennimatas"
-
-
-
-
-
Dublin, Irland, D07 WKW8
- Rekruttering
- Mater Private Hospital
-
Ta kontakt med:
- Gabor Szeplaki, Prof.
-
-
-
-
-
Ramat Gan, Israel, 52621
- Rekruttering
- Sheba Medical Center
-
Ta kontakt med:
- Roy Beinart, MD
-
Tel Aviv, Israel, 6423906
- Rekruttering
- Tel Aviv Sourasky Medical Center
-
Ta kontakt med:
- Raphael Rosso, Professor
-
Tel Aviv, Israel, 62431
- Rekruttering
- Tel Aviv Sourask Medical Center
-
Ta kontakt med:
- Raphael Rosso, Professor
-
-
-
-
-
Modena, Italia, 41124
- Rekruttering
- Policlinico di Modena
-
Ta kontakt med:
- Giuseppe Boriani, Prof.
-
Roma, Italia, 00168
- Rekruttering
- Policlinico Universitario Agostino Gemelli
-
Ta kontakt med:
- Gemma Pelargonio, MD
-
Roma, Italia, 00169
- Rekruttering
- Policlinico Casilino
-
Ta kontakt med:
- Leonardo Calò, MD
-
Roma, Italia, 00186
- Rekruttering
- Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina
-
Ta kontakt med:
- Stefano Bianchi, MD
-
-
-
-
-
Madrid, Spania, 28040
- Rekruttering
- Hospital Clinico San Carlos
-
Ta kontakt med:
- Nicasio Pérez Castellano, MD
-
San Cristóbal de La Laguna, Spania, 38320
- Rekruttering
- Hospital Universitario de Canarias
-
Ta kontakt med:
- Francisco Bosa Ojeda, MD
-
Santa Cruz de Tenerife, Spania, 38010
- Rekruttering
- Hospital Nuestra Señora de La Candelaria
-
Ta kontakt med:
- Luis A. Acosta, MD
-
Zaragoza, Spania, 50009
- Rekruttering
- Hospital Universitario Miguel Servet
-
Ta kontakt med:
- Antonio Asso Abadía, MD
-
-
-
-
-
London, Storbritannia, EC1A 7BE
- Rekruttering
- St. Bartholomew's Hospital
-
Ta kontakt med:
- Ross Hunter, Prof.
-
Manchester, Storbritannia, M13 9WL
- Rekruttering
- Manchester Heart Center
-
Ta kontakt med:
- Charles Pearman, MD
-
-
-
-
-
Berlin, Tyskland, 12687
- Rekruttering
- Unfallkrankenhaus Berlin Marzahn
-
Ta kontakt med:
- Corinna Lenz, MD
-
Bochum, Tyskland, 44791
- Fullført
- Augusta Kranken Anstalt GmbH
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: OTHER
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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. |
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
System-related complication free rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Eszter Pais, MD, Boston Scientific Corporation
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SOCRATES - C2157
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .