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