Heart FailureNCT05761249
BIOSTREAM.HF HeartInsight
An observational study of Heart Failure, run by Biotronik SE & Co. KG at 7 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- HeartInsight activation
- How many people
- 100 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 2 May 2023to 9 Jul 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HeartFailure patients will be recruited by their primary care clinic based on the in/exclusion criteria.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Czechia2 sites
Nemocnice Ceske Budejovice, a.s.
České Budějovice
Fakultní nemocnice Olomouc
Olomouc
About this study
Official title: 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.
- Conditions
- Heart Failure
- Being tested
- HeartInsight activation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartInsight activationOther
HeartInsight is activated at enrollment. The attending physicians are free on how to integrate HeartInsight in the patient care. Any treatment is based on routine care according to guidleines. Only documentation occurs on how the physicians use HeartInsight and actions taken in response to HeartInsight alerts
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of WHF Hospitalization After HeartInsight Activation
Calculation of worsening heart failure hospitalization events per patient year during study participation when HeartInsight is active. A worsening heart failure hospitalization event was defined according to ACC/AHA cardiovascular endpoint standards (Hicks et al., JACC 2015) as an urgent hospitalization for heart failure that included new or worsening heart failure symptoms, objective clinical evidence of worsening heart failure, and initiation or intensification of heart failure-specific treatment.
Measured: through study completion, an average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start2 May 2023
- Primary completion9 Jul 2025
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761249
- Sponsor's protocol ID
- CR033
- Status last verified
- Sep 2026
- First submitted
- 7 Feb 2023
- Last updated
- 9 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices - HeartInsight Substudy
- ClinicalTrials.gov ID
- NCT05761249
- Acronym / sponsor ID
- CR033
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 2 May 2023 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 9 Mar 2023 (actual)
- Results
- Posted 9 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HeartFailure patients will be recruited by their primary care clinic based on the in/exclusion criteria.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartInsight activationHeartInsight is activated at enrollment. The attending physicians are free on how to integrate HeartInsight in the patient care. Any treatment is based on routine care according to guidleines. Only documentation occurs on how the physicians use HeartInsight and actions taken in response to HeartInsight alerts | Other | – |
Primary outcome
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. A worsening heart failure hospitalization event was defined according to ACC/AHA cardiovascular endpoint standards (Hicks et al., JACC 2015) as an urgent hospitalization for heart failure that included new or worsening heart failure symptoms, objective clinical evidence of worsening heart failure, and initiation or intensification of heart failure-specific treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Biotronik SE & Co. KG at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Czechia, Hungary, France, Latvia, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of WHF Hospitalization After HeartInsight Activation (time frame: through study completion, an average of 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.