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

NCT04203576 | Active Not Recruiting DMC

• 1 other identifier: TF01-CID04
• Study Type: interventional
• Target: 50
• Locations: 5 countries
• Sites: 13

Brief Summary

First in Human Clinical Investigation of the FIRE1 Device/System to evaluate the feasibility and safety of implanting the FIRE1 system in up to 50 stable HF patients.

Conditions

Heart Failure

Keywords

Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  3 months

• Primary Technical Endpoint - Signal acquisition from the FIRE1 sensor

  Technical success defined as signal acquisition immediately post implantation and at an attended clinic visit.

  3 months

Secondary Outcomes (2)

• Secondary Safety Endpoint: Freedom from symptomatic access site thrombosis confirmed by ultrasound

  3 months

• Secondary Technical Endpoint - Successful transmission of FIRE1 signal.

  3 months

Study Arms (1)

FIRE1 System

EXPERIMENTAL

FIRE1 System

Device: FIRE1 System

Interventions

FIRE1 System DEVICE

FIRE1 System

FIRE1 System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Foundry Innovation & Research 1, Limited (FIRE1): lead

Study Sites (13)

Nemocnice Na Homolce

Prague, Praha 5, 150 30, Czechia

Location

Fakultní Nemocnice Brno

Brno, 625 00, Czechia

Location

Israeli-Georgian Medical Research Clinic Helsikor

Tbilisi, Georgia

Location

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

Location

Galway University Hospital

Galway, H91 YR71, Ireland

Location

Erasmus University Medical Center

Rotterdam, Dr. Molewaterplein 40, 3015 GD, Netherlands

Location

University Medical Center, Groningen

Groningen, Hanzeplein 1, 9713 GZ, Netherlands

Location

Royal Bournemouth Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

Golden Jubilee National Hospital

Glasgow, G81 4DY, United Kingdom

Location

Glenfield Hospital

Leicester, LE3 9QP, United Kingdom

Location

Royal Brompton Hospital Sydney Street

London, SW3 6NP, United Kingdom

Location

Queen Alexandra Hospital

Portsmouth, PO6 3LY, United Kingdom

Location

University Hospital Southampton

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• Kalra PR, Gogorishvili I, Khabeishvili G, Malek F, Toman O, Critoph C, Flett AS, Cowburn PJ, Mehra MR, Sheridan WS, Britton JR, Buxo T, Kealy RM, Kent A, Greene BR, Guha K, Gardner RS, Loke I, Vazir A, Brugts JJ, Gray A, Testani JM, Damman K. First-in-Human Implantable Inferior Vena Cava Sensor for Remote Care in Heart Failure: FUTURE-HF. JACC Heart Fail. 2025 Jun;13(6):1000-1010. doi: 10.1016/j.jchf.2025.01.019. Epub 2025 Apr 9.

  PMID: 40208140 DERIVED

MeSH Terms

Conditions

Heart Failure; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

• Annette Kent

  Clinical Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 18, 2019
• Study Start: November 22, 2019
• Primary Completion: December 10, 2024
• Study Completion (Estimated): September 30, 2029
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GE (2); CZ (2); NL (2); IE (1); GB (6)