BoStOn SCientific Rhythm MAnagemenT REgiStry
ConditionCardiac Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorBoston Scientific Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Implant
DeviceIn 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.
Electrophysiologic procedure
Procedure/SurgeryIn 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.
Treatment groups
12,500 Participants
are divided into 1 treatment groupGroup A: BSC Product Use2 interventions
Trial outcomes
Primary outcomes
1
System-related complication free rate
Freedom from complications related to system
Time frame
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 year2
Rate of product related performance deficiencies per product or product group
Performance of product/product group at implant/procedure
Time frame
CRM implant on day 0; EP procedure on day 03
Rate of product related performance deficiencies per product or product group
Performance of product/product group through the implanted duration
Time frame
CRM implant on day 0 through the implanted duration up to 10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov