Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Biotronik SE & Co. KG
- Enrollment
- 3030
- Locations
- 114
- Primary Endpoint
- Number of patient deaths
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of patient deaths
Time Frame: throughout study duration, average of 3.5 years; annual evaluations
Number of all-cause mortality
Number of patients with cerebrovascular events
Time Frame: throughout study duration, average of 3.5 years; annual evaluations
Number of cerebrovascular events requiring hospitalization
Assessment of patients benefit from CRT
Time Frame: throughout study duration, average of 3.5 years; annual evaluations
Documentation of NYHA classification \[I-IV\]
Documentation of LVEF
Time Frame: throughout study duration, average of 3.5 years; annual evaluations
Left ventricular ejection fraction \[%\]
Number of cardiovascular adverse events
Time Frame: throughout study duration, average of 3.5 years; annual evaluations
Number of unplanned hospitalization for cardiovascular cause
Number of patients with worsening of heart failure events
Time Frame: throughout study duration, average of 3.5 years; annual evaluations
Number of unplanned hospitalization for worsening of heart failure
Number of all adverse device effects
Time Frame: throughout study duration, average of 3.5 years; annual evaluations
Number of all adverse device effects
Number of patient deaths with cardiovascular cause
Time Frame: throughout study duration, average of 3.5 years; annual evaluations
Number of patient deaths with cardiovascular cause
Number of all cause hospitalization
Time Frame: throughout study duration, average of 3.5 years; annual evaluations
Number of all cause hospitalization
Number of all device deficiencies
Time Frame: throughout study duration, average of 3.5 years; annual evaluations
Number of all device deficiencies
Documentation of LVESV
Time Frame: throughout study duration, average of 3.5 years; annual evaluations
Left ventricular end-systolic volume \[ml\]