FIRE1, First In Human Clinical Investigation of the FIRE1 System in Heart Failure Patients
Sponsor: Foundry Innovation & Research 1 (FIRE1)
This is a prospective, single arm, open label, multicenter phase 2 study of the safety and technical feasibility of the FIRE1TM system in 50 patients with heart failure. Patients receive a FIRE1TM system implanted in the inferior vena cava. This sensor can register changes in the size of the inferior vena cava. Reading is done daily by the patient by (briefly) wearing a band around the abdomen containing an antenna. Safety measures will include an assessment of all adverse events. Subjects will remain in this study for 24 months.
Study Team:
Research nurse: Maaike Sietzema
Coordinator: Greetje de Jong
sub-investigator: Iris Beldhuis