BIOSTREAM.HF HeartInsight

January 12, 2026 updated by: Biotronik SE & Co. KG

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

The main goal is to learn how HeartInsight is used in clinical routine care. HeartInsight is a heart failure monitoring and notification tool within BIOTRONIK's Home Monitoring System. HeartInsight combines patient data as collected by the implanted devices to alert the attending physicians to impending worsening of heart failure events of the patients. This study will create a sound and seamless documentation of approximately 150 HeartInsight alerts, their processing, subsequent interventions and disease progressions. The data will be analyzed to characterize and quantify the use of HeartInsight in a clinical routine set-up.The patient population consists of heart failure patients with BIOTRONIK CRT-D devices that support HeartInsight.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Olomouc, Czechia
        • Fakultni nemocnice Olomouc
      • České Budějovice, Czechia
        • Nemocnice Ceske Budejovice, a.s.
  • France
      • Brest, France
        • CHU de Brest
  • Hungary
      • Budapest, Hungary
        • Semmelweis University
      • Pécs, Hungary
        • The University of Pécs
  • Latvia
      • Riga, Latvia
        • Pauls Stradins Clinical University Hospital
  • Portugal
      • Lisbon, Portugal
        • Hospital de Santa Maria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

HeartFailure patients will be recruited by their primary care clinic based on the in/exclusion criteria.

Description

Inclusion Criteria:

  • Patient willing and able to give consent
  • Participation in BIO|STREAM.HF
  • HeartInsight-capable CRT-D device implanted or planned to be implanted
  • Symptomatic heart failure NYHA class II or III within 45 days prior to enrollment
  • HeartInsight score available or planned use of HeartInsight
  • History of worsening of heart failure hospitalization or unscheduled outpatient visit with intravenous diuretic therapy for acute worsening of heart failure
  • Patient is willing and able to utilize BIOTRONIK Home Monitoring via CardioMessenger and has sufficient mobile network coverage

Exclusion Criteria:

  • Patient with permanent atrial fibrillation or 100% atrial pacing
  • Patient is not implanted with an atrial or DX lead or atrial sensing is deactivated
  • History of patient incompliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of WHF hospitalization after HeartInsight activation
Time Frame: through study completion, an average of 1.5 years
Calculation of worsening heart failure hospitalization events per patient year during study participation when HeartInsight is active
through study completion, an average of 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2023

Primary Completion (Actual)

July 9, 2025

Study Completion (Actual)

July 9, 2025

Study Registration Dates

First Submitted

February 7, 2023

First Submitted That Met QC Criteria

February 27, 2023

First Posted (Actual)

March 9, 2023

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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