Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03366545

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Canberra Heart Rhythm Foundation, Canberra, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac Resynchronization Therapy (CRT)

Device

Observation and documentation of routine care for CRT patients

Primary outcomes

  1. Number of cardiovascular adverse events

    Time frame: throughout study duration, average of 3.5 years; annual evaluations

    Number of unplanned hospitalization for cardiovascular cause

  2. Number of patient deaths

    Time frame: throughout study duration, average of 3.5 years; annual evaluations

    Number of all-cause mortality

  3. Number of all cause hospitalization

    Time frame: throughout study duration, average of 3.5 years; annual evaluations

    Number of all cause hospitalization

  4. 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

  5. Number of patients with cerebrovascular events

    Time frame: throughout study duration, average of 3.5 years; annual evaluations

    Number of cerebrovascular events requiring hospitalization

  6. Number of all adverse device effects

    Time frame: throughout study duration, average of 3.5 years; annual evaluations

    Number of all adverse device effects

  7. Number of all device deficiencies

    Time frame: throughout study duration, average of 3.5 years; annual evaluations

    Number of all device deficiencies

  8. Assessment of patients benefit from CRT

    Time frame: throughout study duration, average of 3.5 years; annual evaluations

    Documentation of NYHA classification [I-IV]

  9. 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

  10. Documentation of LVEF

    Time frame: throughout study duration, average of 3.5 years; annual evaluations

    Left ventricular ejection fraction [%]

  11. Documentation of LVESV

    Time frame: throughout study duration, average of 3.5 years; annual evaluations

    Left ventricular end-systolic volume [ml]

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Acronym: BIO|STREAM HF

Important dates

Study start
2018
Primary completion
2025
Study completion
2026
First posted
Dec 8, 2017
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.