BIOSTREAM.HF version 2.0
Research type
Research Study
Full title
BIO|STREAM.HF: Observation of clinical routine care for heart failure patients implanted with BIOTRONIK CRT devices
IRAS ID
237481
Contact name
Marcus Knott
Contact email
Sponsor organisation
BIOTRONIK SE & Co. KG
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 4 months, 1 days
Research summary
BIO|STREAM.HF - Observation of clinical routine care for heart failure patients implanted with BIOTRONIK CRT devices.\n\nBIO|STREAM.HF is an open-label, prospective, non-randomized, non-controlled, international, multi-centre observational registry. The registry collects data from patients implanted with Biotronik Cardiac Resynchronization Therapy (CRT) device systems.\n\nThe main objective of the registry is to perform long-term assessment of outcome, efficacy and any previously unidentified safety aspects of Biotronik CRT, in an unselected, ‘real-world’ clinical setting. Another important objective is to observe patient status and device data to find possible predictors for heart failure events and to identify areas of potential improvement for CRT and for CRT device settings. Furthermore, the registry will form a generic platform for future registry-based trials and analyses, which are yet to be determined, but which are expected to address specific scientific topics and/or additional safety aspects.\n\nCardiac Resynchronization Therapy (CRT) is used to treat heart failure. Despite optimal therapy, hospitalizations for CRT patients are still common and a significant percentage of patients do not have the desired response to the therapy.\n\nClinical observation of CRT patients may be used to identify predictors of heart failure events which could prompt early medical intervention, thereby potentially reducing hospitalizations and mortality.\n\nClose supervision of the patients’ clinical status combined with heart rhythm and technical data collected by the implanted devices may lead to the discovery of predictors for worsening of heart failure and may also reveal ways to improve therapy and thus lead to better patient outcomes.\n\nThe registry will enrol 3000 patients from approximately 100 implanting sites, internationally.\n\nEnrolment is expected to take 60 months to complete. Each patient will remain in the registry until the last enrolled patient has been followed-up for 12 months.\n
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
18/YH/0483
Date of REC Opinion
6 Dec 2018
REC opinion
Favourable Opinion