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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04203576
Recruitment Status : Recruiting
First Posted : December 18, 2019
Last Update Posted : January 31, 2023
Sponsor:
Information provided by (Responsible Party):
Foundry Innovation & Research 1, Limited (FIRE1)

Study Description
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Brief Summary:
First in Human Clinical Investigation of the FIRE1 Device/System to evaluate the feasibility and safety of implanting the FIRE1 system in stable HF patients.

Condition or disease Intervention/treatment Phase
Heart Failure Device: FIRE1 System Not Applicable

Detailed Description:
Eligible patients who have HF and were hospitalised/treated for an episode of worsening HF within the last 6 months. This non-randomised FIH trial will enrol a total of 50 patients and the primary safety and technical endpoints will be assessed at 3 months. Safety measures will include an assessment of all adverse events. Subjects will remain in this study for 24 months.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: First In Human Clinical Investigation of the FIRE1 System in Heart Failure Patients
Actual Study Start Date : November 22, 2019
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: FIRE1 System
FIRE1 System
 Device: FIRE1 System
FIRE1 System


Outcome Measures
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Primary Outcome Measures :
  1. Primary Safety Endpoint - Procedural success and freedom from FIRE1 sensor complications [ Time Frame: 3 months ]
    The primary, composite endpoint is success of the FIRE1 sensor, which includes procedural success defined as sensor deployment at the intended site without acute device or procedural related complications and freedom from sensor complications including device migration, clinically significant fracture and/ or clinically significant perforation of the Inferior Vena Cava (IVC) or symptomatic caval thrombosis.

  2. Primary Technical Endpoint - Signal acquisition from the FIRE1 sensor [ Time Frame: 3 months ]
    Technical success defined as signal acquisition immediately post implantation and at an attended clinic visit.


Secondary Outcome Measures :
  1. Secondary Safety Endpoint: Freedom from symptomatic access site thrombosis confirmed by ultrasound [ Time Frame: 3 months ]
    Freedom from symptomatic access site thrombosis confirmed by ultrasound. Freedom from a significant hematoma (defined as requiring intervention, transfusion or prolonging hospitalisation).

  2. Secondary Technical Endpoint - Successful transmission of FIRE1 signal. [ Time Frame: 3 months ]
    Successful transmission of a FIRE1 sensor reading from the patient's home.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria

  • Adults 18 years or older with heart failure with any of the following in the past 6 months: a decompensation due to heart failure resulting in a heart failure hospitalisation, heart failure treatment in a hospital day-care setting or urgent outpatient heart failure visit
  • Receiving treatment in accordance with internationally recognised guidelines.
  • Signed patient informed consent form

Main Exclusion Criteria:

  • Significant comorbidity that would interfere with the ability to safely complete the clinical investigation protocol
  • Patients with an estimated Glomerular Filtration Rate (eGFR) < 30 ml/min
  • Patients with IVC filter placement in situ, abnormal IVC or femoral venous anatomy or known congenital malformation or absence of IVC or occlusive or free-floating thrombus in the IVC
  • Patients with implantable ventricular assist device (LVAD, RVAD, BiVAD) in situ
  • Patients with Cardiovascular Implantable Electronic Device (CIED) implanted ≤ 3 months prior to enrolment
  • Patients with conditions associated with occlusion of the IVC, iliac or common femoral veins (e.g. venous leg ulcers)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04203576


Contacts
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Contact: Annette Kent 0035319089012 clinical@fire1foundry.com

Locations
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Czechia
Nemocnice Na Homolce Recruiting
Prague, Praha 5, Czechia, 150 30
Fakultní Nemocnice Brno Recruiting
Brno, Czechia, 625 00
Georgia
Israeli-Georgian Medical Research Clinic Helsikor Recruiting
Tbilisi, Georgia
Tbilisi Heart and Vascular Clinic Recruiting
Tbilisi, Georgia
United Kingdom
Royal Bournemouth Hospital Recruiting
Bournemouth, United Kingdom, BH7 7DW
Golden Jubilee National Hospital Not yet recruiting
Glasgow, United Kingdom, G81 4DY
Glenfield Hospital Not yet recruiting
Leicester, United Kingdom, LE3 9QP
Royal Brompton Hospital Sydney Street Not yet recruiting
London, United Kingdom, SW3 6NP
Queen Alexandra Hospital Not yet recruiting
Portsmouth, United Kingdom, PO6 3LY
University Hospital Southampton Recruiting
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Foundry Innovation & Research 1, Limited (FIRE1)
Investigators
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Study Director: Annette Kent Clinical Director
More Information
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Responsible Party: Foundry Innovation & Research 1, Limited (FIRE1)
ClinicalTrials.gov Identifier: NCT04203576    
Other Study ID Numbers: TF01-CID04
First Posted: December 18, 2019    Key Record Dates
Last Update Posted: January 31, 2023
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Foundry Innovation & Research 1, Limited (FIRE1):
Cardiovascular Disease
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases