FIRE1 System / Heart Failure · Interventional Study

First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients (FUTURE-HF)

ClinicalTrials.gov · September 3, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for an ongoing first-in-human feasibility and safety investigation of an implantable cardiac device (FIRE1 System) in heart failure patients. No results are reported in this record. The study aims to enroll up to 50 patients and evaluate procedural success, freedom from sensor complications, and signal acquisition at 3 months, but outcomes remain pending.

What was studied

Interventional, Single Group, Open label, Diagnostic purpose. Heart Failure; age from 18 Years. Intervention: FIRE1 System. n = 50. 13 sites across 5 countries.

Key findings

Safety

Primary endpoints are technical and safety measures, not clinical outcomes such as mortality, hospitalisation, or functional improvement.

Who this may help

No clinical impact can be assessed until results are reported. This registry record documents the planned investigation; clinicians should await publication of safety and feasibility outcomes before any clinical interpretation.

Plain-language summary

This is a first-in-human feasibility and safety study with no results yet reported; the registry record describes planned enrollment and endpoints only.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Primary Safety Endpoint - Procedural success and freedom from FIRE1 sensor complications (assessed at 3 months); Primary Technical Endpoint - Signal acquisition from the FIRE1 sensor (assessed at 3 months)

DesignInterventional, Single Group, Open label, Diagnostic purpose

PopulationHeart Failure; age from 18 Years

Sample size50

InterventionFIRE1 System

Setting13 sites across 5 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment50

Primary Safety EndpointProcedural success and freedom from FIRE1 sensor complications at 3 months

Primary Technical EndpointSignal acquisition from the FIRE1 sensor at 3 months

Clinical bottom line

Caveats

This is a registry record only; no results are reported.
Primary endpoints are technical and safety measures, not clinical outcomes such as mortality, hospitalisation, or functional improvement.
Single-arm design with no comparator arm.
Follow-up duration is 3 months; longer-term durability and efficacy data are not reported.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Single-arm interventional device study; first-in-human design inherently limits evidence strength.

Directness

moderate

Primary endpoints are procedural success and sensor signal acquisition, not clinical outcomes.

Consistency

insufficient

Registry record reports no results; consistency cannot be assessed.

Risk of bias

insufficient

No methods or results reported; bias assessment not possible from registry record.

Sample adequacy

limited

Planned enrollment 50 participants; typical for first-in-human feasibility studies.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT04203576). This is a study registration, not published results. Lead sponsor: Foundry Innovation & Research 1, Limited (FIRE1). Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 50 participants (ESTIMATED). Conditions: Heart Failure. Interventions: DEVICE: FIRE1 System. Primary outcome measures: Primary Safety Endpoint - Procedural success and freedom from FIRE1 sensor complications , 3 months; Primary Technical Endpoint - Signal acquisition from the FIRE1 sensor , 3 months. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

FIRE1 SystemNCT04203576Heart FailureFoundry Innovation & Research 1, Limited (FIRE1)