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Can a tiny sensor inside a vein predict heart failure crises?

NCT ID NCT04203576

Disease control Sponsor: Foundry Innovation & Research 1, Limited (FIRE1) 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This first-in-human trial tests a small device called the FIRE1 System, which is implanted in a major vein to monitor fluid buildup in people with heart failure. The study enrolls up to 50 adults who have recently needed hospital care for heart failure. Researchers check whether the implant is safe, stays in place, and successfully sends signals that could one day alert doctors to early signs of trouble.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FIRE1 System, an implantable sensor that monitors the inferior vena cava for signs of fluid overload in heart failure patients
What this could lead to
If it works, this implant could give doctors early warning of worsening heart failure, potentially reducing hospital stays and helping patients manage their condition at home.
What could go wrong
This is an early, small safety and feasibility study in 50 people. The sensor could move, fracture, or cause blood clots, and it is not yet known if the readings will reliably improve patient outcomes.

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

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2019

Expected to finish

Sep 2029

An estimate. End dates often move.

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.

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.

Main Inclusion Criteria * Adults 18 years or older with heart failure with any of the following in the past 6 months: a decompensation due to heart failure resulting in a heart failure hospitalisation, heart failure treatment in a hospital day-care setting or urgent outpatient heart failure visit * Receiving treatment in accordance with internationally recognised guidelines. * Signed patient informed consent form Main Exclusion Criteria: * Significant comorbidity that would interfere with the ability to safely complete the clinical investigation protocol * Patients with an estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min * Patients with IVC filter placement in situ, abnormal IVC or femoral venous anatomy or known congenital malformation or absence of IVC or occlusive or free-floating thrombus in the IVC * Patients with implantable ventricular assist device (LVAD, RVAD, BiVAD) in situ * Patients with Cardiovascular Implantable Electronic Device (CIED) implanted ≤ 3 months prior to enrolment * Patients with conditions associated with occlusion of the IVC, iliac or common femoral veins (e.g. venous leg ulcers)

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder 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

  • Erasmus University Medical Center

    Rotterdam, Dr. Molewaterplein 40, 3015 GD, Netherlands

  • Fakultní Nemocnice Brno

    Brno, 625 00, Czechia

  • Galway University Hospital

    Galway, H91 YR71, Ireland

  • Glenfield Hospital

    Leicester, LE3 9QP, United Kingdom

  • Golden Jubilee National Hospital

    Glasgow, G81 4DY, United Kingdom

  • Israeli-Georgian Medical Research Clinic Helsikor

    Tbilisi, Georgia

  • Nemocnice Na Homolce

    Prague, Praha 5, 150 30, Czechia

  • Queen Alexandra Hospital

    Portsmouth, PO6 3LY, United Kingdom

  • Royal Bournemouth Hospital

    Bournemouth, BH7 7DW, United Kingdom

  • Royal Brompton Hospital Sydney Street

    London, SW3 6NP, United Kingdom

  • Tbilisi Heart and Vascular Clinic

    Tbilisi, Georgia

  • University Hospital Southampton

    Southampton, SO16 6YD, United Kingdom

  • University Medical Center, Groningen

    Groningen, Hanzeplein 1, 9713 GZ, Netherlands

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