First In Human Clinical Investigation of the FIRE1* System in Heart Failure Patients_ Pilot Study of the FIRE1TM System in Heart Failure Patients

• Conditions: Heart Failure; 10019280

• Registration Number: NL-OMON53958
• Lead Sponsor: FIRE1 (Foundry Innovation and Research 1 Ltd)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

1. Adults aged 18 years or older with a diagnosis of HF for greater than 90
days, NYHA Class II or III HF and receiving treatment, in accordance with
internationally recognized guidelines and institutional practices to include
standard of care drug/device therapies as deemed appropriate.
2. a) Have experienced a HF decompensation in the past 12 months prior to
consent, defined as either: Hospitalisation for HF, HF treatment in a hospital
day-care setting or urgent outpatient HF visit for IV diuretics
OR
b) Elevated N-terminal-pro-brain natriuretic peptide (NT-proBNP) >= or brain
natriuretic peptide (BNP) within 30 days prior to consent or at screening
- Subjects in sinus rhythm NT-proBNP >=800 pg/mL or BNP >=300 pg/mL
- Subjects with Atrial Fibrillation (AF) NT-proBNP >=1200 pg/m Lor BNP >=350
pg/mL.
For subjects treated with an angiotensin receptor neprilysin inhibitor (ARNI)
only NT-proBNP values should be considered.
3. IVC diameter within the landing zone (between the hepatic and renal veins)
of between 14 mm and 28 mm
4. Minimum landing zone length of 60 mm.
5. Provide informed consent for participation in the clinical investigation and
be willing and able to comply with the required assessments, treatment
instructions and follow-up visits.

Exclusion Criteria

1. Significant comorbidity or FIRE1* System usability or compliance concern,
that would interfere with the ability to safely complete or capably participate
in the CIP.
2. Patients with an estimated Glomerular Filtration Rate < 30 ml/min at
screening.
3. Patients that are pregnant or nursing or planning a pregnancy within 1 year
of screening.
4. Expected lifespan from time of enrolment of < 1 year, as assessed by the
Investigator.
5. Evidence of advanced, end-stage HF, with NYHA IV, and/or currently treated
with intravenous inotropes and/or vasopressors.
6. Patients with abdominal circumference of greater than 128 cm at screening.
7. Patients who exceed angiographic table weight limit at screening.
8. Patients with IVC filter placement in situ, abnormal IVC or femoral venous
anatomy, known congenital malformation, absence of IVC, or occlusive or
free-floating thrombus in the IVC.
9. Patients who have an implantable ventricular assist device (Left Ventricular
Assist Device (LVAD), Right Ventricular Assist Device (RVAD) or Biventricular
Assist Device (BiVAD) in situ.
10. Patients with Cardiovascular Implantable Electronic Device (CIED) implanted
<= 3 months prior to screening.
11. Patients who have received tissue/organ transplant or planned advanced
therapies including a tissue/organ transplant or an implantation of a
ventricular assist device within the next 180 days.
12. Patients who have planned procedures requiring a venous femoral access
within 90 days of the FIRE1* Sensor implantation.
13. Patients with echocardiographic evidence of severe tricuspid stenosis or
severe tricuspid regurgitation.
14. Patients with current echocardiographic evidence of severe aortic valve
stenosis.
15. Patients with a known history of thrombophilia or other hypercoagulable
state.
16. Patients with venous thrombosis or thromboembolism in the 6 months prior to
screening.
17. Patients with conditions associated with occlusion of the IVC, iliac or
common femoral veins (e.g., venous leg ulcers).
18. Patients with hypersensitivity or allergy to aspirin and/or antiplatelet
agents used or FIRE1* Gen 2 Sensor components (Nitinol, Polyurethane (PU),
Nylon, Polyethylene Terephthalate (PET) and Gold) or contrast media.
19. Patients with an active systemic infection at screening.
20. Participation in any other concurrent clinical investigation.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety<br /><br>The primary, composite endpoint is success of the FIRE1* Sensor at 3 months (12<br /><br>weeks), including the following:<br /><br>1. Procedural success defined as Sensor deployment at the intended site without<br /><br>acute device or procedural related complications and<br /><br>2. Freedom from Sensor complications, including device migration, clinically<br /><br>significant fracture and/ or clinically significant perforation of the Inferior<br /><br>Vena Cava (IVC), or symptomatic caval thrombosis<br /><br><br /><br>Technical<br /><br>Technical success defined as signal acquisition<br /><br>1. Immediately post implantation and<br /><br>2. At an attended clinic visit within the first 3 months (12 weeks) of Sensor<br /><br>implantation</p><br>