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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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

Study details
    Heart Failure

NCT03366545

Biotronik SE & Co. KG

30 April 2024

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