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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)

Tracking Information
First Submitted Date  ICMJE December 12, 2019
First Posted Date  ICMJE December 18, 2019
Last Update Posted Date January 31, 2023
Actual Study Start Date  ICMJE November 22, 2019
Estimated Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2023)
  • 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).
  • Secondary Technical Endpoint - Successful transmission of FIRE1 signal. [ Time Frame: 3 months ]
    Successful transmission of a FIRE1 sensor reading from the patient's home.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2019)
  • 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).
  • Secondary Technical Endpoint - Successful transmission of FIRE1 signal. [ Time Frame: 4 months ]
    Successful transmission of a FIRE1 sensor reading from the patient's home. Signal acquisition during fluid loading procedure.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients (FUTURE-HF)
Official Title  ICMJE First In Human Clinical Investigation of the FIRE1 System in Heart Failure Patients
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Heart Failure
Intervention  ICMJE Device: FIRE1 System
FIRE1 System
Study Arms  ICMJE Experimental: FIRE1 System
FIRE1 System
Intervention: Device: FIRE1 System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2022)		 50
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2019)		 10
Estimated Study Completion Date  ICMJE August 31, 2025
Estimated Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Annette Kent 0035319089012 clinical@fire1foundry.com
Listed Location Countries  ICMJE Czechia,   Georgia,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04203576
Other Study ID Numbers  ICMJE TF01-CID04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Foundry Innovation & Research 1, Limited (FIRE1)
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Foundry Innovation & Research 1, Limited (FIRE1)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Annette Kent Clinical Director
PRS Account Foundry Innovation & Research 1, Limited (FIRE1)
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP