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

  • STATUS
    Recruiting
  • End date
    Apr 28, 2022
  • participants needed
    10
  • sponsor
    Foundry Innovation & Research 1, Limited (FIRE1)
Updated on 17 February 2021
Investigator
Annette Kent
Primary Contact
Nemocnice Na Homolce (1.2 mi away) Contact
+2 other location

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.

Description

Eligible patients must be stable HF patients, NYHA class III who were hospitalised/treated for an episode of worsening HF within the last 12 months. This non-randomised FIH trial will enrol a total of 10 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 on this study for 24 months.

Details
Condition Heart Failure NYHA Class III
Treatment FIRE1 System
Clinical Study IdentifierNCT04203576
SponsorFoundry Innovation & Research 1, Limited (FIRE1)
Last Modified on17 February 2021

Eligibility

Yes No Not Sure

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

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)
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note