Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04828811 |
| Other study ID # |
2020-488 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 3, 2021 |
| Est. completion date |
March 3, 2041 |
Study information
| Verified date |
March 2021 |
| Source |
Universitair Ziekenhuis Brussel |
| Contact |
Carlo de Asmundis, MD PhD |
| Phone |
003224776009 |
| Email |
hrmc.reserch[@]uzbrussel.be |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
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.
Description:
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.
