Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices

Study Overview
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Brief Summary
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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.

Official Title
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Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Cardiac Resynchronization Therapy (CRT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cardiac Resynchronization Therapy (CRT)|Observation and documentation of routine care for CRT patients|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cardiovascular adverse events | Number of unplanned hospitalization for cardiovascular cause | throughout study duration, average of 3.5 years; annual evaluations | 
| Number of patient deaths | Number of all-cause mortality | throughout study duration, average of 3.5 years; annual evaluations | 
| Number of all cause hospitalization | Number of all cause hospitalization | throughout study duration, average of 3.5 years; annual evaluations | 
| Number of patients with worsening of heart failure events | Number of unplanned hospitalization for worsening of heart failure | throughout study duration, average of 3.5 years; annual evaluations | 
| Number of patients with cerebrovascular events | Number of cerebrovascular events requiring hospitalization | throughout study duration, average of 3.5 years; annual evaluations | 
| Number of all adverse device effects | Number of all adverse device effects | throughout study duration, average of 3.5 years; annual evaluations | 
| Number of all device deficiencies | Number of all device deficiencies | throughout study duration, average of 3.5 years; annual evaluations | 
| Assessment of patients benefit from CRT | Documentation of NYHA classification [I-IV] | throughout study duration, average of 3.5 years; annual evaluations | 
| Number of patient deaths with cardiovascular cause | Number of patient deaths with cardiovascular cause | throughout study duration, average of 3.5 years; annual evaluations | 
| Documentation of LVEF | Left ventricular ejection fraction [%] | throughout study duration, average of 3.5 years; annual evaluations | 
| Documentation of LVESV | Left ventricular end-systolic volume [ml] | throughout study duration, average of 3.5 years; annual evaluations | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRT, cardiac resynchronization therapy, clinical routine