Heart Failure
Conditions
Keywords
cardiac resynchronization therapy, CRT, clinical routine
Brief summary
The registry is primarily designed to assess outcome, efficacy and residual safety aspects of CRT based on long-term data from an unselected, real-life clinical set-up. Moreover, the observation of the patient status should help to find possible predictors for HF events and to identify areas of improvement for CRT and for CRT device settings.
Interventions
Observation and documentation of routine care for CRT patients
Sponsors
Biotronik SE & Co. KG
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Planned de novo implantation of or upgrade to a CRT system for treatment according to the intended use * Patient is able to understand the nature of the registry and has provided written informed consent * Patient is willing and able to use the CardioMessenger and accepts the Home Monitoring concept * Remote monitoring using the Home Monitoring® platform is planned for the patient
Exclusion criteria
* Standard contraindication for CRT * Already or previously implanted with CRT system * • Age \< 18 years * Participation in another interventional clinical investigation other than the registry-based trials of BIO\|STREAM.HF * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of cardiovascular adverse events | throughout study duration, average of 3.5 years; annual evaluations | Number of unplanned hospitalization for cardiovascular cause |
| Number of patient deaths | throughout study duration, average of 3.5 years; annual evaluations | Number of all-cause mortality |
| Number of all cause hospitalization | throughout study duration, average of 3.5 years; annual evaluations | Number of all cause hospitalization |
| Number of patients with worsening of heart failure events | throughout study duration, average of 3.5 years; annual evaluations | Number of unplanned hospitalization for worsening of heart failure |
| Number of patients with cerebrovascular events | throughout study duration, average of 3.5 years; annual evaluations | Number of cerebrovascular events requiring hospitalization |
| Number of all adverse device effects | throughout study duration, average of 3.5 years; annual evaluations | Number of all adverse device effects |
| Number of all device deficiencies | throughout study duration, average of 3.5 years; annual evaluations | Number of all device deficiencies |
| Assessment of patients benefit from CRT | throughout study duration, average of 3.5 years; annual evaluations | Documentation of NYHA classification \[I-IV\] |
| Number of patient deaths with cardiovascular cause | throughout study duration, average of 3.5 years; annual evaluations | Number of patient deaths with cardiovascular cause |
| Documentation of LVEF | throughout study duration, average of 3.5 years; annual evaluations | Left ventricular ejection fraction \[%\] |
| Documentation of LVESV | throughout study duration, average of 3.5 years; annual evaluations | Left ventricular end-systolic volume \[ml\] |
Countries
Australia, Austria, Belgium, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Latvia, Poland, Portugal, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, United Kingdom
Outcome results
None listed