BIO|STREAM.HF

obServation of clinical rouTine caRe of hEart failure pAtients iMplanted with BIOTRONIK CRT devices

The number of patients recruited by Canberra Heart Rhythm: 3

Non – randomised, non-controlled, unblinded, multicentre international study
 
Objectives:
  • long term assessment of outcome, efficacy and residual risks of CRT in an unsettled, real-life clinical set up
  • Find possible predictors for heart failure events
  • Identify areas of improvement for CRT and for CRT settings
  • Create generic registry as a platform for future registry – based trials and analyses, which will address specific scientific topics and safety aspects

Synopsis of the study:

  • collecting long term data for CRT in real-life population
  • 5 year enrolment period
  • Target 3000 patients CRT-D, CRT-P
  • Expected average follow up - 42 months

Inclusion Criteria
 
  • Planned implantation or upgrade to CRT for intended treatment according to guidelines
  • Willing to use the CardioMessenger and accepts the Home monitoring concept
Exclusion Criteria
 
  • Standard contraindication for CRT 
  • Already implanted with CRT
  • Pregnant or breastfeeding
Endpoints:
 
  • Major Adverse Cardiac Event
  • All cause hospitalisations
  • All cause mortality
  • NYHA classification
  • LVEF
  • LV end systolic volume