Clinical Investigation of FIRE1 System in HF Patients – FUTURE HF
First In Human Clinical Investigation of the FIRE1 System in Heart Failure Patients
Paul R Kalra
Duration of Study in the UK
2 years, 6 months, 2 days
The FIRE1 System is a new medical device designed for patients with heart failure.
Heart failure patients often exhibit signs and symptoms of fluid accumulation in the body, which may indicate a deterioration of heart function.
We know, from previous studies, that the size of the inferior vena cava, the main vein returning blood from the lower half of the body back to the heart, changes. Information about these changes can be used to assess the deterioration of the heart and thereby reveal the possibility of worsening heart failure symptoms, before any of these symptoms appear.
The FIRE1 System consists of a specialised sensor implanted in the patient's body and a belt that is wrapped around the abdomen to pick up the sensor signal which is recorded, stored on the study laptop and sent to a secure FIRE1 database.
The sensor is implanted into the patient's inferior vena cava, that monitors the first signs of increased fluid accumulation in the body, which may indicate a deterioration of heart function.
This study aims to successfully and safely implant the FIRE1 sensor, and to detect and understand the signal from the implanted sensor and how the signal changes with fluid changes in the body. The aim is to learn more about the safety, technical feasibility and information collected from the FIRE1 System.
The study is an early-stage, exploratory pilot clinical investigation aimed at evaluating the limitations and potential benefits of the FIRE1 System. It is a single arm, multi-centre study recruiting up to 50 patients who have a diagnosis of HF and have been recently hospitalised, from up to 20 sites for a duration of 24 months.
West of Scotland REC 4
Date of REC Opinion
27 Jul 2022
Further Information Favourable Opinion