First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients (FUTURE-HF)
NCT ID: NCT04203576
Last Updated: 2025-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2019-11-22
2029-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Early Feasibility Study of the NORM™ System in Heart Failure Patients (FUTURE-HFII)
NCT05763407
Biomarkers to Classify Heart Failure
NCT02347722
Future Innovations in Novel Detection of Heart Failure FIND-HF
NCT05756127
Study to Collect High-Resolution ECG Data and Patient Insights on Heart Failure Care
NCT06809686
TransitionCHF Systolic Dysfunction to Congestive Heart Failure Cohort Study
NCT02323750
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FIRE1 System
FIRE1 System
FIRE1 System
FIRE1 System
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FIRE1 System
FIRE1 System
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Receiving treatment in accordance with internationally recognised guidelines.
* Signed patient informed consent form
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Foundry Innovation & Research 1, Limited (FIRE1)
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Annette Kent
Role: STUDY_DIRECTOR
Clinical Director
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nemocnice Na Homolce
Prague, Praha 5, Czechia
Fakultní Nemocnice Brno
Brno, , Czechia
Israeli-Georgian Medical Research Clinic Helsikor
Tbilisi, , Georgia
Tbilisi Heart and Vascular Clinic
Tbilisi, , Georgia
Galway University Hospital
Galway, , Ireland
Erasmus University Medical Center
Rotterdam, Dr. Molewaterplein 40, Netherlands
University Medical Center, Groningen
Groningen, Hanzeplein 1, Netherlands
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Golden Jubilee National Hospital
Glasgow, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
Royal Brompton Hospital Sydney Street
London, , United Kingdom
Queen Alexandra Hospital
Portsmouth, , United Kingdom
University Hospital Southampton
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TF01-CID04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.