FIRE1 System for Heart Failure

Recruiting at 4 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

Trial Summary

What is the purpose of this trial?

Early Feasibility Study of the NORM™ System in Heart Failure Patients

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.

Is the FIRE1 System for Heart Failure safe for humans?

Initial clinical results suggest that vagus nerve stimulation, which may be related to the FIRE1 System, is safe and tolerable in heart failure patients, potentially improving quality of life and heart function. ^{1 2 3 4 5}

How does the FIRE1 System treatment for heart failure differ from other treatments?

The FIRE1 System is unique because it involves an implantable device that allows patients to directly measure and manage their heart's pressure in real-time, offering a more precise and personalized approach compared to traditional drug therapies or cardiac devices that primarily focus on rhythm disturbances or mechanical support. ^{6 7 8 9 10}

Research Team

Annette Kent

Principal Investigator

Director Clinical US

Eligibility Criteria

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.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

Group I: FIRE1 System Experimental Treatment 1 Intervention

FIRE1 System

Who Is Running the Clinical Trial?

Foundry Innovation & Research 1, Limited (FIRE1)

Lead Sponsor

Trials

2

Recruited

80+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Delineating Pathways to Death by Multisystem Organ Failure in Patients With a Left Ventricular Assist Device. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

The use of beta-blockade therapy in treatment of congestive heart failure. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Telemetric long-term assessment of autonomic function in experimental heart failure. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Adverse events in contemporary continuous-flow left ventricular assist devices: A multi-institutional comparison shows significant differences. [2015]

5. Germany pubmed.ncbi.nlm.nih.gov

[Vagus stimulation. Mechanisms and current clinical importance in heart failure]. [2021]

6. Australia pubmed.ncbi.nlm.nih.gov

The Heartpod implantable heart failure therapy system. [2022]

7. Poland pubmed.ncbi.nlm.nih.gov

Vagus nerve stimulation: A new approach to reduce heart failure. [2022]

8. United States 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. [2022]

9. China 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]. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Device therapy for heart failure. [2019]