FIRE1 System for Heart Failure

Recruiting at 5 trial locations

Overseen By Carolyn Borme

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Foundry Innovation & Research 1, Limited (FIRE1)

Must be taking: Loop diuretics

Disqualifiers: Severe valvular disease, eGFR < 25, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the FIRE1 System, a new device designed to assist people with heart failure. The study aims to determine if this system can improve heart function and daily life for those living with heart failure for more than 90 days. It seeks participants who have experienced worsening heart failure symptoms and required hospital visits in the past year. Participants should be on specific heart medications and have symptoms affecting daily activities. Those who can use a device at home with internet access may be a good fit for the trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future heart failure treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires that you continue taking a daily dose of loop diuretic like furosemide for at least two weeks before screening.

What prior data suggests that the FIRE1 System is safe for heart failure patients?

Research has shown that the FIRE1 System, which includes a small sensor placed inside the body, has undergone testing in people. Early results suggest that this device is safe and can be used without major issues. In previous studies, participants had the sensor implanted without serious problems, indicating it is generally well-tolerated. However, the FIRE1 System remains under study and is not yet approved for use in the United States. While the initial data looks promising, more research is needed to fully understand any possible risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The FIRE1 System is unique for treating heart failure because it introduces a novel device-based approach rather than relying on medication. Unlike standard treatments such as ACE inhibitors or beta-blockers, which primarily focus on managing symptoms and slowing disease progression, the FIRE1 System aims to improve heart function directly by modulating the autonomic nervous system. This innovative mechanism has the potential to provide a more targeted and efficient way to enhance heart performance, offering hope for improved outcomes in heart failure patients. Researchers are particularly excited about this system's ability to offer a new pathway for managing heart failure, which could complement or even surpass current medical therapies.

What evidence suggests that the FIRE1 System is effective for heart failure?

Research shows that the FIRE1 System is a promising tool for managing heart failure. Studies have found that the system's sensor, placed in the inferior vena cava, is safe and effectively monitors and manages fluid changes in patients. Fluid buildup is a major issue in heart failure, causing symptoms like swelling and difficulty breathing. Early results suggest that the FIRE1 System could improve patient health by addressing these fluid changes. So far, the data is encouraging, showing potential benefits in heart failure care. ^{1 2 3 6 7}

Who Is on the Research Team?

Carolyn Borme

Principal Investigator

Director Clinical US

Are You a Good Fit for This Trial?

This trial is for adults over 18 with heart failure, on stable medication for at least a month, and have been hospitalized or needed unscheduled care due to heart failure in the past year. They must be taking daily diuretics and meet specific criteria based on natriuretic peptide levels. Excluded are those with severe comorbidities, very low kidney function, abnormal veins, certain valvular diseases or devices implanted recently.

Inclusion Criteria

I have been taking a water pill daily for at least 2 weeks.

I was hospitalized or needed urgent care for heart failure in the last year.

Signed patient informed consent form

Exclusion Criteria

You have had a heart transplant or a ventricular assist device, or you are planning to have advanced heart treatments within the next year.

I had a heart valve procedure without open surgery in the last 3 months.

I have a blockage in the veins in my abdomen or legs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the FIRE1 System and are monitored for primary safety and technical endpoints

3 months

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

21 months

Periodic visits for safety assessments

What Are the Treatments Tested in This Trial?

Interventions

• FIRE1 System

Trial Overview The FIRE1 System is being tested for safety and feasibility in patients with stable heart failure. This early study will involve implanting the system to see how well it works and if it's safe in this patient group.

How Is the Trial Designed?

Group I: NORM™ System Experimental Treatment 1 Intervention

NORM™ System

Who Is Running the Clinical Trial?

Foundry Innovation & Research 1, Limited (FIRE1)

Lead Sponsor

Trials

2

Recruited

80+

Published Research Related to This Trial

Vagus nerve stimulation (VNS) has shown promise in treating advanced heart failure (HF) by significantly improving symptoms, increasing left ventricular ejection fraction, and reducing ventricular volumes over a 12-month follow-up period.

The initial study demonstrated the feasibility and safety of VNS in HF patients, suggesting that enhancing parasympathetic activity could be a new therapeutic approach for those already on optimal medical therapy, although further research with larger trials is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vagus nerve stimulation: A new approach to reduce heart failure. Klein, HU., Ferrari, GM.[2022]

In a study of 694 patients with cardiac resynchronization therapy devices, a combined heart failure diagnostic algorithm significantly predicted the risk of hospitalization due to heart failure, with a 5.5-fold increased risk for those with positive diagnostic criteria.

The algorithm's effectiveness remained strong even after adjusting for other clinical factors, highlighting its potential utility in monitoring and managing patients with systolic left ventricular dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined heart failure device diagnostics identify patients at higher risk of subsequent heart failure hospitalizations: results from PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) study. Whellan, DJ., Ousdigian, KT., Al-Khatib, SM., et al.[2022]

Implanted medical devices are becoming increasingly important in heart failure (HF) management, with categories including monitoring devices, rhythm treatment devices, mechanical efficiency enhancers, and heart replacement devices, showing promise in improving patient outcomes.

Studies, such as the MADIT II trial, have demonstrated that devices like implantable cardioverter defibrillators (ICDs) can significantly reduce mortality in heart failure patients, while biventricular pacing has been shown to enhance symptoms and exercise capacity over intermediate durations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device therapy for heart failure. Boehmer, JP.[2019]

The study analyzed 3,765 adverse events (AEs) from 536 patients with left ventricular assist devices (LVADs) and identified two distinct clusters of patients based on their AE profiles leading to multisystem organ failure (MSOF) death.

Patients in the early-death cluster (418 patients) experienced a median survival of only 1 month due to sequences of renal failure and respiratory failure, while the late-death cluster (118 patients) had a median survival of 11 months, primarily suffering from chronic bleeding and infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delineating Pathways to Death by Multisystem Organ Failure in Patients With a Left Ventricular Assist Device. Seese, L., Movahedi, F., Antaki, J., et al.[2021]

In a study involving 6 beagle dogs, heart failure (HF) was induced and autonomic nervous system (ANS) function was continuously monitored using telemetry devices, revealing significant decreases in heart rate variability and other ANS parameters during HF conditions.

The study highlights the potential of digital technologies for precise and continuous assessment of ANS function in HF, which could lead to earlier detection of autonomic imbalances and improve the evaluation of novel treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemetric long-term assessment of autonomic function in experimental heart failure. Boden, K., Pongratanakul, P., Vogel, J., et al.[2023]

Chronic heart failure is associated with increased activation of the sympathetic nervous system, which may lead to worsening heart function and higher risks of sudden death and exercise intolerance.

Beta-blockers have been shown to be beneficial in treating chronic heart failure by selectively blocking the beta-adrenergic system, potentially improving patient outcomes and reducing morbidity and mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of beta-blockade therapy in treatment of congestive heart failure. Sobotka, PA., Gunnar, RM.[2007]

Chronic vagus nerve stimulation in heart failure patients with severe systolic dysfunction has shown to be safe and tolerable, potentially improving quality of life and heart function.

The benefits of vagus nerve stimulation may arise from various mechanisms, including reduced heart rate, improved heart rate variability, decreased inflammation, and antiarrhythmic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Vagus stimulation. Mechanisms and current clinical importance in heart failure]. Kuschyk, J., Borggrefe, M.[2021]

The HeartCon left ventricular assist device (LVAD) significantly improved heart function and quality of life in 20 adult patients with end-stage heart failure, as evidenced by reductions in left ventricular end-diastolic diameter and increases in left ventricular ejection fraction after 90 days.

The procedure was safe, with no mechanical failures reported and a low incidence of serious complications, although further studies are needed to assess long-term effects and complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Short-term effect of HeartCon left ventricular assist device on the treatment of 20 adult patients with end-stage heart failure]. Wang, W., Song, Y., Zhang, Y., et al.[2023]

The Heartpod device developed by Savacor allows for real-time measurement of left atrial pressure in patients with congestive heart failure, enabling them to monitor their condition more effectively.

This innovative implantable device empowers patients to adjust their treatment based on precise intra-cardiac pressure data, potentially improving management of their heart failure symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Heartpod implantable heart failure therapy system. Walton, AS., Krum, H.[2022]

In a study of 734 patients implanted with continuous-flow left ventricular assist devices (LVADs), the HeartWare HVAD was associated with a significantly higher risk of stroke compared to the HeartMate II (HR: 1.8), indicating a safety concern for patients using this device.

Overall mortality rates were similar between the two devices (7.3% for HMII and 7.5% for HVAD), but the analysis revealed that while gastrointestinal bleeding and infections were comparable, the HVAD showed a concerning trend of increased stroke risk over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in contemporary continuous-flow left ventricular assist devices: A multi-institutional comparison shows significant differences. Stulak, JM., Davis, ME., Haglund, N., et al.[2015]

Citations

1. jacc.org jacc.org/doi/10.1016/j.jchf.2025.01.019

First-in-Human Inferior Vena Cava Sensor for Remote HF Care This first-in-human experience demonstrated that the implantation of an IVC sensor was safe and feasible.

2. fire1foundry.com fire1foundry.com/wp-content/uploads/2023/09/THT-CRF-FIRE1-EFS-Presentation_Uriel_02Mar2024_FINAL.pdf

the FIRE1 System in Heart Failure Patients The FIRE1TM System is investigational, not approved in the US. The following data and analyses have not been reviewed by any regulatory bodies, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04203576

First in Human Clinical Investigation of the FIRE1 System ... Subjects will remain in this study for 24 months. Official Title. First In Human Clinical Investigation of the FIRE1 System in Heart Failure Patients.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1071916424006730

FIRE1 IVC Sensor Effective For Fluid Shifts In Heart Failure 239. Novel FIRE1 Inferior Vena Cava Sensor Effective In Tracking And Managing Fluid Shifts In A Heart Failure Patient.

5. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/fire1-novel-heart-failure-system-now-a-reality-in-ireland/

FIRE1 Novel Heart Failure System Now A Reality In Ireland This study aims to assess the effectiveness of FIRE1 in improving outcomes for individuals with heart failure. The system addresses fluid ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2213177925001726

First-in-Human Implantable Inferior Vena Cava Sensor for ... This first-in-human experience demonstrated that the implantation of an IVC sensor was safe and feasible.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ejhf.2822

Safety and performance of a novel implantable sensor in ... The FIRE1 system includes an implanted sensor and an external electronic system utilizing a radiofrequency antenna embedded in an externally ...