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Clinical Trial
. 2025 Jun;13(6):1000-1010.
doi: 10.1016/j.jchf.2025.01.019. Epub 2025 Apr 9.

First-in-Human Implantable Inferior Vena Cava Sensor for Remote Care in Heart Failure: FUTURE-HF

Paul R Kalra  1 , Irakli Gogorishvili  2 , George Khabeishvili  3 , Filip Málek  4 , Ondřej Toman  5 , Chris Critoph  6 , Andrew S Flett  7 , Peter J Cowburn  7 , Mandeep R Mehra  8 , William S Sheridan  9 , John R Britton  9 , Teresa Buxo  9 , Robyn M Kealy  9 , Annette Kent  9 , Barry R Greene  9 , Kaushik Guha  1 , Roy S Gardner  10 , Ian Loke  11 , Ali Vazir  12 , Jasper J Brugts  13 , Alastair Gray  14 , Jeffrey M Testani  15 , Kevin Damman  16
Affiliations
Free article
Clinical Trial

First-in-Human Implantable Inferior Vena Cava Sensor for Remote Care in Heart Failure: FUTURE-HF

Paul R Kalra et al. JACC Heart Fail. 2025 Jun.
Free article

Abstract

Background: Variations of inferior vena cava (IVC) area and collapsibility serve as early markers of congestion and predict risk for heart failure (HF) events.

Objectives: The aim of this first-in-human study (FUTURE-HF [First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients]) was to evaluate the safety and feasibility of a novel implantable IVC sensor for remote management in patients with HF. This paper is the final report on primary (3-month) and exploratory (6-month) endpoints.

Methods: Patients with HF hospitalizations within the previous year, with elevated natriuretic peptide levels, and on optimal HF treatment were included. The primary safety endpoints were procedural success without device- or procedure-related complications at 3 months. The primary technical endpoint was signal acquisition following implantation and at a clinic visit within 3 months. Sensor-derived IVC area was compared with computed tomography (CT)-based IVC dimensions. Patient adherence to daily readings and exploratory clinical findings at 6 months were assessed.

Results: Fifty patients underwent successful implantation (mean age 65 ± 9 years, 14% women, 72% in NYHA functional class III), with 49 contributing to the primary safety and technical endpoints at 3 months. Sensor-derived IVC area demonstrated excellent agreement with CT measurement (mean absolute error 13.53 mm2 [3.55%] R2 = 0.98). Median adherence was 96% at 6-month follow-up. Exploratory analyses of clinical outcomes suggested improvements in N-terminal pro-B-type natriuretic peptide, NYHA functional class, and quality of life and reduced HF events.

Conclusions: This first-in-human experience demonstrated that the implantation of an IVC sensor was safe and feasible. Sensor-derived IVC area demonstrated excellent correlation with CT-derived IVC area, and exploratory clinical outcomes suggest that this may serve as a novel tool for ambulatory management of congestion to facilitate remote care in HF. (First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients [FUTURE-HF]; NCT04203576).

Keywords: FUTURE-HF; congestion monitoring; heart failure; inferior vena cava sensor; remote care; volume status.

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Conflict of interest statement

Funding Support and Author Disclosures This study was funded by FIRE1 (Foundry Innovation and Research 1). The sponsor participated in data generation, analysis of the raw signal data, and review and approval of the manuscript. Dr Kalra has received research grants from Pharmacosmos; and has received consulting and lecturing honoraria for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, FIRE1, Novartis, Pfizer, Pharmacosmos, Servier, CSL, and Vifor. Dr Gardner has received research funding from Abbott, AnaCardio, Boston Scientific, the British Heart Foundation, FIRE1, and Roche Diagnostics; and has received consulting fees from Abbott, AnaCardio, AstraZeneca, Boehringer Ingelheim, Boston Scientific, Novartis, Pfizer, and Pharmacosmos. Dr Brugts has participated in speaker engagements and advisory boards for AstraZeneca, Abbott, Boehringer Ingelheim, Bayer, Novartis, and Vifor in the past 3 years. Dr Damman has received speaker and consulting fees to his employer from Abbott, AstraZeneca, Boehringer Ingelheim, FIRE1, and Novartis. Dr Gray has received consulting fees from FIRE1; and has received funding from Medtronic and Biotronik. Dr Mehra has received personal fees from FIRE1 as a consultant; has received consulting fees paid to Brigham and Women’s Hospital from Abbott and Cadrenal Therapeutics for clinical trial leadership; and has received personal fees from Moderna, Natera, Transmedics, Paragonix Technologies, NuPulseCV, Second Heart Assist, FineHeart, and Leviticus outside the submitted work. Dr Testani has received grants and/or personal fees from 3ive Labs, Bayer, Bristol Myers Squibb, AstraZeneca, Novartis, Cardionomic, MagentaMed, Reprieve, FIRE1, W.L. Gore, Sanofi, Sequana Medical, Otsuka, Abbott, Merck, Windtree Therapeutics, Lexicon Pharmaceuticals, preCARDIA, Relypsa, Regeneron, Becton Dickinson, Edwards Lifesciences, Corteria, and Eli Lilly; has a patent for the treatment of diuretic resistance issued to Yale and Corvidia Therapeutics, a patented method for measuring renalase issued to Yale, and a patent for the treatment of diuretic resistance pending with Reprieve. Dr Critoph has received consulting and lecturing honoraria from Abbott, Novartis, and AstraZeneca. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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