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Implantable Device

FIRE1 System for Heart Failure

N/A
Waitlist Available
Research Sponsored by Foundry Innovation & Research 1, Limited (FIRE1)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic heart failure, as evidenced by a screening B-type natriuretic peptide (BNP) ≥300 pg/mL or N-terminal-pro-B type natriuretic peptide (NT-proBNP) ≥1000 pg/mL, or BNP ≥500 pg/mL or NT-proBNP ≥1,600 pg/mL for subjects presenting with atrial fibrillation at screening. For subjects treated with an angiotensin receptor neprilysin inhibitor (ARNI) in the 4 weeks prior to screening only NT-proBNP values should be considered
Patients meeting diagnostic criteria for heart failure diagnosis for greater than 90 days and are on optimally tolerated medical therapy for at least 30 days, as recommended according to current AHA/ACC guidelines regardless of ejection fraction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial tests if implanting a new device in stable heart failure patients is safe and feasible.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects of the FIRE1 System aren't detailed here, potential risks may include complications from implantation like infection or bleeding, device malfunction, and any unforeseen impacts on heart function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have chronic heart failure with specific heart failure markers above normal levels.
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I have been diagnosed with heart failure for over 90 days and have been on recommended treatment for at least 30 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Effectiveness Endpoint - Device Performance
Primary Safety Endpoint - Freedom from Sensor Complications
Primary Safety Endpoint - Procedural success
Secondary outcome measures
Exploratory Safety Outcome

Trial Design

1Treatment groups
Experimental Treatment
Group I: FIRE1 SystemExperimental Treatment1 Intervention
FIRE1 System

Find a Location

Who is running the clinical trial?

Foundry Innovation & Research 1, Limited (FIRE1)Lead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Heart Failure
50 Patients Enrolled for Heart Failure

Media Library

FIRE1 System (Implantable Device) Clinical Trial Eligibility Overview. Trial Name: NCT05763407 — N/A
Heart Failure Research Study Groups: FIRE1 System
Heart Failure Clinical Trial 2023: FIRE1 System Highlights & Side Effects. Trial Name: NCT05763407 — N/A
FIRE1 System (Implantable Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05763407 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you tell me the number of participating sites within this state for this research project?

"Currently, the trial is being conducted in 4 different sites. To simplify travel related concerns if you decide to take part, it's recommended that you select the closest location; these include Rochester, Columbus and Austin among others."

Answered by AI

Are new participants still welcome to join this investigation?

"This research study, which was originally made public on June 19th 2023 is presently recruiting patients. The most recent modifications were observed on August 18th 2023 according to information present on clinicaltrials.gov."

Answered by AI

How many participants are allowed to take part in this experiment?

"The sponsor of this medical study, Foundry Innovation & Research 1 Limited (FIRE1), requires 15 patients that meet the inclusion criteria to operate. Rochester General Hospital in Rochester and Ohio State University Wexner Medical Centre in Columbus are among the sites where this trial will be conducted."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Early Feasibility Study of the FIRE1™ System in Heart Failure Patients (FUTURE-HF2)
2023. "Early Feasibility Study of the FIRE1™ System in Heart Failure Patients (FUTURE-HF2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05763407.
~0 spots leftby May 2024
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