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

Heart Failure Clinical Trial

Official title:
First In Human Clinical Investigation of the FIRE1 System in Heart Failure Patients

Clinical Trial 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.

Clinical Trial Description

Eligible patients who have HF and were hospitalised/treated for an episode of worsening HF within the last 6 months. This non-randomised FIH trial will enrol a total of 50 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 in this study for 24 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04203576
Study type Interventional
Source Foundry Innovation & Research 1, Limited (FIRE1)
Contact Annette Kent
Phone 0035319089012
Email clinical@fire1foundry.com
Status Recruiting
Phase N/A
Start date November 22, 2019
Completion date August 31, 2026
View Details
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