Tiny heart monitor could predict heart failure Flare-Ups
NCT ID NCT06989580
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times
Summary
This study is testing a special heart monitor, the BIOMONITOR IV, in 300 people with heart failure who also have irregular heartbeats. The device tracks heart activity, fluid levels, and breathing patterns to see if it can predict when heart failure gets worse. Researchers hope to develop an early warning system that helps doctors step in sooner and keep patients out of the hospital.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BIOMONITOR IV implantable cardiac monitor with study software
- What this could lead to
- If successful, this could lead to a predictive algorithm that alerts doctors early to worsening heart failure, potentially reducing hospital visits and deaths.
- What could go wrong
- This is an observational data-collection study, not a treatment trial. The algorithm may not prove accurate enough to change outcomes, and results may not apply to all heart failure patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient has diagnosed heart failure for ≥90 days and current symptoms compatible with NYHA class II-III (according to most recent assessment) * At least ONE of the following: At least one documented admission with a primary diagnosis of worsening heart failure within last 12 months prior to enrollment; OR Unscheduled outpatient visit with increase of oral loop diuretics (more than 2-fold) or IV diuretic or ultrafiltration therapy for acute WHF within last 6 months prior to enrollment; OR elevated NT-proBNP/BNP values within last 3 months prior to enrollment i.e.: If LVEF \>50% --\> Patients in SR: \>450 / \>150 pg/ml; Patients with AF present: \>900 / \>300 pg/ml If LVEF \<50% --\> Patients in SR: \>900 / \>300 pg/ml; Patients with AF present: \>1800 / \>450 pg/ml * Ability to understand the nature of the study * Willingness to provide written informed consent * Ability and willingness to perform follow-up visits at the study site and via phone * Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept Exclusion Criteria: * Implanted with pacemaker, ICD or CRT device or ICM * Class I indication for a pacemaker, ICD or CRT according to current guidelines. * Permanent or long-standing persistent AF * Stroke, MI or PCI/CABG within 3 months prior to enrollment * Patient is on chronic renal or peritoneal dialysis * Patient has complex adult congenital heart disease * Patient has active cancer involving chemotherapy, immunotherapy or radiation therapy * Patient life expectancy is less than 1 year * Age \<18 years * Patient is participating in any other device or drug trial that may interfere with the treatment or protocol of this study or may significantly affect the study outcomes
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peter Osypka Herzzentrum
NOT_YET_RECRUITINGMunich, Germany
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Ziekenhuis Oost Limburg AV
RECRUITINGGenk, Belgium
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