Clinical trial NCT04823663: BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)
Official title: BoStOn SCientific Rhythm MAnagemenT REgiStry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2021-04-01
Enrollment: 12500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

Brief 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). 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: System-related complication free rate
timeFrame: 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
measure: Rate of product related performance deficiencies per product or product group
timeFrame: CRM implant on day 0; EP procedure on day 0
measure: Rate of product related performance deficiencies per product or product group
timeFrame: CRM implant on day 0 through the implanted duration up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Yvoir
country: Belgium
facility: CHU UCL Namur - Site Godinne
city: Quebec City
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
state: Quebec
city: Brest
country: France
facility: CHRU de Brest, Hôpital de la Cavale Blanche
city: Clermont-Ferrand
country: France
facility: CHRU de Clermont-Ferrand
city: Lomme
country: France
facility: Hopital Saint Philibert
city: Pau
country: France
facility: CHG de Pau
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin Marzahn
city: Bochum
country: Germany
facility: Augusta Kranken Anstalt GmbH
city: Athens
country: Greece
facility: General Hospital of Athens "G. Gennimatas"
city: Athens
country: Greece
facility: Onassis Cardiac Surgery Center
city: Dublin
country: Ireland
facility: Mater Private Hospital
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center
city: Modena
country: Italy
facility: Policlinico di Modena
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Roma
country: Italy
facility: Policlinico Casilino
city: Roma
country: Italy
facility: Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Nuestra Señora de La Candelaria
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
city: Manchester
country: United Kingdom
facility: Manchester Heart Center
Study officials:
affiliation: Boston Scientific Corporation
name: Eszter Pais, MD
role: STUDY_DIRECTOR
References: