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

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
FIRE1 System
Sponsored by
Foundry Innovation & Research 1, Limited (FIRE1)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring Cardiovascular Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria

  • Adults 18 years or older with NYHA Class III heart failure with any of the following in the past 12 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
  • Diagnosis of heart failure and receiving heart failure medical therapy for > 3 months
  • On stable optimized HF therapy
  • 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) or prosthetic valves in situ
  • Patients with Cardiac Resynchronization Device (CRT) or implantable cardioverter-defibrillator (ICD) 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)

Sites / Locations

  • Nemocnice Na HomolceRecruiting
  • Fakultní Nemocnice BrnoRecruiting
  • Israeli-Georgian Medical Research Clinic HelsikorRecruiting
  • Tbilisi Heart and Vascular ClinicRecruiting
  • Royal Bournemouth HospitalRecruiting
  • Golden Jubilee National Hospital
  • Glenfield Hospital
  • Royal Brompton Hospital Sydney Street
  • Queen Alexandra Hospital
  • University Hospital SouthamptonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FIRE1 System

Arm Description

FIRE1 System

Outcomes

Primary Outcome Measures

Primary Safety Endpoint - Procedural success and freedom from FIRE1 sensor complications
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
Technical success defined as signal acquisition immediately post implantation and at an attended clinic visit.

Secondary Outcome Measures

Secondary Safety Endpoint: Freedom from symptomatic access site thrombosis confirmed by ultrasound
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.
Successful transmission of a FIRE1 sensor reading from the patient's home.

Full Information

First Posted
December 12, 2019
Last Updated
January 30, 2023
Sponsor
Foundry Innovation & Research 1, Limited (FIRE1)
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1. Study Identification

Unique Protocol Identification Number
NCT04203576
Brief Title
First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients (FUTURE-HF)
Official Title
First In Human Clinical Investigation of the FIRE1 System in Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2019 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundry Innovation & Research 1, Limited (FIRE1)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Cardiovascular Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FIRE1 System
Arm Type
Experimental
Arm Description
FIRE1 System
Intervention Type
Device
Intervention Name(s)
FIRE1 System
Intervention Description
FIRE1 System
Primary Outcome Measure Information:
Title
Primary Safety Endpoint - Procedural success and freedom from FIRE1 sensor complications
Description
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.
Time Frame
3 months
Title
Primary Technical Endpoint - Signal acquisition from the FIRE1 sensor
Description
Technical success defined as signal acquisition immediately post implantation and at an attended clinic visit.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Secondary Safety Endpoint: Freedom from symptomatic access site thrombosis confirmed by ultrasound
Description
Freedom from symptomatic access site thrombosis confirmed by ultrasound. Freedom from a significant hematoma (defined as requiring intervention, transfusion or prolonging hospitalisation).
Time Frame
3 months
Title
Secondary Technical Endpoint - Successful transmission of FIRE1 signal.
Description
Successful transmission of a FIRE1 sensor reading from the patient's home.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annette Kent
Phone
0035319089012
Email
clinical@fire1foundry.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annette Kent
Organizational Affiliation
Clinical Director
Official's Role
Study Director
Facility Information:
Facility Name
Nemocnice Na Homolce
City
Prague
State/Province
Praha 5
ZIP/Postal Code
150 30
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultní Nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Israeli-Georgian Medical Research Clinic Helsikor
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Tbilisi Heart and Vascular Clinic
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Golden Jubilee National Hospital
City
Glasgow
ZIP/Postal Code
G81 4DY
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Glenfield Hospital
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Royal Brompton Hospital Sydney Street
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Queen Alexandra Hospital
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
University Hospital Southampton
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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