BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)

Cardiac Disease Clinical Trial

— SOCRATES  

Official title:

BoStOn SCientific Rhythm MAnagemenT REgiStry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04823663
• Other study ID #: C2157
• Status: Recruiting
• Start date: March 31, 2021
• Est. completion date: December 31, 2030

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: Jens Goetzke, Dipl.Ing.
• Phone: 1-800-227-3422
• Email: Jens.Goetzke[@]bsci.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT04828811

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12500
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette
Belgium	CHU UCL Namur - Site Godinne	Yvoir
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Quebec	Quebec City	Quebec
France	CHRU de Brest, Hôpital de la Cavale Blanche	Brest
France	CHRU de Clermont-Ferrand	Clermont-Ferrand
France	Hopital Saint Philibert	Lomme
France	CHG de Pau	Pau
France	CHU de Saint-Etienne	Saint-Étienne
Germany	Unfallkrankenhaus Berlin Marzahn	Berlin
Germany	Augusta Kranken Anstalt GmbH	Bochum
Greece	General Hospital of Athens "G. Gennimatas"	Athens
Greece	Onassis Cardiac Surgery Center	Athens
Ireland	Mater Private Hospital	Dublin
Israel	Sheba Medical Center	Ramat-Gan
Italy	Policlinico di Modena	Modena
Italy	Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina	Roma
Italy	Policlinico Casilino	Roma
Italy	Policlinico Universitario Agostino Gemelli	Roma
Spain	Hospital Universitario de Canarias	La Laguna
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Nuestra Señora de La Candelaria	Santa Cruz De Tenerife
Spain	Hospital Universitario Miguel Servet	Zaragoza
United Kingdom	Manchester Heart Center	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Belgium,  Canada,  France,  Germany,  Greece,  Ireland,  Israel,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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