Heart FailureNCT04203576
First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients (FUTURE-HF)
A study testing FIRE1 System in people with Heart Failure, run by Foundry Innovation & Research 1, Limited (FIRE1) at 13 sites in 5 countries.
Trial summary
First in Human Clinical Investigation of the FIRE1 Device/System to evaluate the feasibility and safety of implanting the FIRE1 system in up to 50 stable HF patients. 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?
- FIRE1 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 22 Nov 2019to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
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)
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
United Kingdom6 sites
Royal Bournemouth Hospital
Bournemouth, BH7 7DW
Golden Jubilee National Hospital
Glasgow, G81 4DY
Glenfield Hospital
Leicester, LE3 9QP
Royal Brompton Hospital Sydney Street
London, SW3 6NP
Queen Alexandra Hospital
Portsmouth, PO6 3LY
University Hospital Southampton
Southampton, SO16 6YD
Czechia2 sites
Fakultní Nemocnice Brno
Brno, 625 00
Nemocnice Na Homolce
Prague, Praha 5, 150 30
Georgia2 sites
Israeli-Georgian Medical Research Clinic Helsikor
Tbilisi
Tbilisi Heart and Vascular Clinic
Tbilisi
Netherlands2 sites
University Medical Center, Groningen
Groningen, Hanzeplein 1, 9713 GZ
Erasmus University Medical Center
Rotterdam, Dr. Molewaterplein 40, 3015 GD
About this study
Official title: First In Human Clinical Investigation of the FIRE1 System in Heart Failure Patients
First in Human Clinical Investigation of the FIRE1 Device/System to evaluate the feasibility and safety of implanting the FIRE1 system in up to 50 stable HF patients.
Read the detailed description
Eligible patients who have HF and were hospitalised/treated for an episode of worsening HF within the last 6 months. This non-randomised FIH trial will enrol a total of 50 patients and the primary safety and technical endpoints will be assessed at 3 months. Safety measures will include an assessment of all adverse events. Subjects will remain in this study for 24 months.
- Conditions
- Heart Failure
- Being tested
- FIRE1 System
- Keywords
- Cardiovascular Disease
- Medical subject headings
- Heart Failure, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIRE1 SystemDevice
FIRE1 System
| Study group | Role | What they receive |
|---|---|---|
| FIRE1 System | Experimental | FIRE1 System Receives: Device: FIRE1 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint - Procedural success and freedom from FIRE1 sensor complications
The primary, composite endpoint is success of the FIRE1 sensor, which includes procedural success defined as sensor deployment at the intended site without acute device or procedural related complications and freedom from sensor complications including device migration, clinically significant fracture and/ or clinically significant perforation of the Inferior Vena Cava (IVC) or symptomatic caval thrombosis.
Measured: 3 months
Primary Technical Endpoint - Signal acquisition from the FIRE1 sensor
Technical success defined as signal acquisition immediately post implantation and at an attended clinic visit.
Measured: 3 months
Secondary outcomes (2)
Secondary Safety Endpoint: Freedom from symptomatic access site thrombosis confirmed by ultrasound
Freedom from symptomatic access site thrombosis confirmed by ultrasound. Freedom from a significant hematoma (defined as requiring intervention, transfusion or prolonging hospitalisation).
Measured: 3 months
Secondary Technical Endpoint - Successful transmission of FIRE1 signal.
Successful transmission of a FIRE1 sensor reading from the patient's home.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start22 Nov 2019
- Primary completion10 Dec 2024
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundry Innovation & Research 1, Limited (FIRE1)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annette Kent, Study director, Clinical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203576
- Sponsor's protocol ID
- TF01-CID04
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2019
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalra PR, Gogorishvili I, Khabeishvili G, Malek F, Toman O, Critoph C, Flett AS, Cowburn PJ, Mehra MR, Sheridan WS, Britton JR, Buxo T, Kealy RM, Kent A, Greene BR, Guha K, Gardner RS, Loke I, Vazir A, Brugts JJ, Gray A, Testani JM, Damman K. First-in-Human Implantable Inferior Vena Cava Sensor for Remote Care in Heart Failure: FUTURE-HF. JACC Heart Fail. 2025 Jun;13(6):1000-1010. doi: 10.1016/j.jchf.2025.01.019. Epub 2025 Apr 9.
PubMed 40208140
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First In Human Clinical Investigation of the FIRE1 System in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT04203576
- Acronym / sponsor ID
- TF01-CID04
- Conditions
- Heart Failure
- Keywords
- Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Foundry Innovation & Research 1, Limited (FIRE1)Industry (pharma, biotech, devices)
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
First in Human Clinical Investigation of the FIRE1 Device/System to evaluate the feasibility and safety of implanting the FIRE1 system in up to 50 stable HF patients.
Detailed description
Eligible patients who have HF and were hospitalised/treated for an episode of worsening HF within the last 6 months. This non-randomised FIH trial will enrol a total of 50 patients and the primary safety and technical endpoints will be assessed at 3 months. Safety measures will include an assessment of all adverse events. Subjects will remain in this study for 24 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FIRE1 System | Experimental | Device: FIRE1 SystemFIRE1 System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| FIRE1 SystemFIRE1 System | Device | FIRE1 System |
Primary outcome
Primary Safety Endpoint - Procedural success and freedom from FIRE1 sensor complications
Time frame: 3 months
The primary, composite endpoint is success of the FIRE1 sensor, which includes procedural success defined as sensor deployment at the intended site without acute device or procedural related complications and freedom from sensor complications including device migration, clinically significant fracture and/ or clinically significant perforation of the Inferior Vena Cava (IVC) or symptomatic caval thrombosis.
Primary Technical Endpoint - Signal acquisition from the FIRE1 sensor
Time frame: 3 months
Technical success defined as signal acquisition immediately post implantation and at an attended clinic visit.
2 secondary outcomes
Secondary Safety Endpoint: Freedom from symptomatic access site thrombosis confirmed by ultrasound
Time frame: 3 months
Secondary Technical Endpoint - Successful transmission of FIRE1 signal.
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Derived from this study: PubMed 40208140Kalra PR, Gogorishvili I, Khabeishvili G, Malek F, Toman O, Critoph C, Flett AS, Cowburn PJ, Mehra MR, Sheridan WS, Britton JR, Buxo T, Kealy RM, Kent A, Greene BR, Guha K, Gardner RS, Loke I, Vazir A, Brugts JJ, Gray A, Testani JM, Damman K. First-in-Human Implantable Inferior Vena Cava Sensor for Remote Care in Heart Failure: FUTURE-HF. JACC Heart Fail. 2025 Jun;13(6):1000-1010. doi: 10.1016/j.jchf.2025.01.019. Epub 2025 Apr 9.
- 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.
Annette Kent study director
Clinical Director
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIRE1 System in people with Heart Failure, run by Foundry Innovation & Research 1, Limited (FIRE1) at 13 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?
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: under way, not looking for participants, as of the sponsor's last update on 3 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 13 sites in United Kingdom, Czechia, Georgia, Netherlands, Ireland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Primary Safety Endpoint - Procedural success and freedom from FIRE1 sensor complications (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04203576, which also lists 1 linked publication.
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 3 Sep 2026.