BIO|STREAM.ICM
Research type
Research Study
Full title
Observation of clinical routine care for patients with BIOTRONIK implantable cardiac monitors (ICMs)
IRAS ID
283821
Contact name
Hannah Worthington
Contact email
Sponsor organisation
Biotronik SE & Co. KG
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 29 days
Research summary
This registry is designed to collect long-term clinical data of outcome, performance and residual safety aspects of the BIOMONITOR III and successor devices in a real-life clinical set-up.
The BIOMONITOR III and successor devices are used to detect and record slow, fast or irregular heartbeats and provides this information to physcians to allow them to to identify the kind of arrhythmias that have occurred, it does not deliver any therapy.
In addition, this registry is set up in a way that it may also be used as a platform for submodules to investigate additional scientific and regulatory aspects while minimizing the additional effort for the investigational sites and patients.
The study will enrol 1000 patients from approximately 40 implanting sites, internationally.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
22/WM/0091
Date of REC Opinion
6 Jun 2022
REC opinion
Further Information Favourable Opinion