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

  • STATUS
    Recruiting
  • End date
    Jun 18, 2025
  • participants needed
    3000
  • sponsor
    Biotronik SE & Co. KG
Updated on 18 April 2021
Investigator
Andreas Peth, Dr.
Primary Contact
Mediclinic Midstream (1.9 mi away) Contact
+90 other location
heart failure
cardiac resynchronization therapy

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.

Details
Condition Heart failure, Heart disease, Congestive Heart Failure, Cardiac Disease, cardiac failure, congestive heart disease
Treatment Cardiac resynchronization therapy (CRT)
Clinical Study IdentifierNCT03366545
SponsorBiotronik SE & Co. KG
Last Modified on18 April 2021

Eligibility

Yes No Not Sure

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
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