Post- Market Clinical Follow-up Clinical Trial
Official title:
BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)
The objective of SOCRATES is to serve as one element within an overarching framework to systematically gather and record clinical data. The data to be collected is defined in separate individual Post- Market Clinical Follow-up (PMCF) Plans developed by Boston Scientific Corporation (BSC). All data will be collected under local standard of care (SoC) conditions of use. The data collected will be used to achieve relevant information about the safety, performance and quality of BSC Rhythm Management (RM) products throughout their entire lifetime. The individual PMCF plans each relate to one or more of BSC's medical devices. The PMCF plans will specify outcomes that will be evaluated per predetermined scientific, clinical or policy purposes using the data of populations treated or diagnosed with the applicable BSC devices. The populations are defined by a particular disease, condition or exposure (i.e. to a device). The data collected will be analysed per separate PMCF Data Analysis Plans (PDAP) linked to the PMCF plans.
Device/System Any commercial BSC RM product (Cardiac Rhythm Management/ Electrophysiology) greater than class I is generally in scope for SOCRATES. Design 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. Planned Number of Subjects SOCRATES intends to enroll a number of subjects that will support the analysis of all the individual 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 groupings1 supported by SOCRATES. Planned Number of Sites/ Countries Sites will be chosen from geographies where there is frequent usage of the approved BSC Cardiac Rhythm Management (CRM) and Electropysiology (EP) product portfolio such as, but not limited to, leads, pulse generators, accessories, programmers for RM; ablation, diagnostic catheters, cables, consoles and workstations for EP. The number of participating sites and geographic locations selected will be reviewed periodically to determine if the sample size is sufficient and to ensure there is adequate representation of BSC product use. As long as SOCRATES is active, there is no upper limit to the total number of sites that may participate. Follow-up Schedule Depending on when a subject is enrolled, data may be collected at the index procedure and subsequently at planned and unplanned follow-up visits. There are no mandated visits at specific timepoints in SOCRATES. The timepoints for visits will be determined by the site solely based on their local standard of care process. Duration 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. Participant Duration 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. Standard duration for follow-up (FU) for each CRM implantable devices and disposable EP devices is detailed in the specific modules referred in Document #92538061, Reference Document Statistical Information. 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 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 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. Released 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. ;