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

Condition(s) studied

Investigational drug(s) / intervention(s)

Cardiac Resynchronization Therapy (CRT): Observation and documentation of routine care for CRT patients

Study 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.

Eligibility

Primary outcome measure(s)

• 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 \[ml\]

Trial sites (114)

+ 74 more sites — see the full list on the official registry below.

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