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Smart device alerts docs to heart trouble before It's too late

NCT ID NCT05761249

Knowledge-focused Sponsor: Biotronik SE & Co. KG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This study looked at how HeartInsight, a monitoring tool inside heart devices, alerts doctors when heart failure gets worse. About 100 patients with special pacemakers took part. The goal was to see how doctors use these alerts in everyday care to prevent hospital visits.

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.

Participants

100 people

The number who actually took part.

Started

May 2023

Finished

Jul 2025

Lead sponsor

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.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure

Contacts and locations

Locations

  • CHU de Brest

    Brest, France

  • Fakultní nemocnice Olomouc

    Olomouc, Czechia

  • Hospital de Santa Maria

    Lisbon, Portugal

  • Nemocnice Ceske Budejovice, a.s.

    České Budějovice, Czechia

  • Pauls Stradins Clinical University Hospital

    Riga, Latvia

  • Semmelweis University

    Budapest, Hungary

  • The University of Pécs

    Pécs, Hungary

More trials for these conditions

Other studies related to the condition(s) this trial covers.