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Effect of the MobiusHD® in Patients With Heart Failure — HF-FIM  

Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:
A Feasibility Study Exploring the Effect of the MobiusHD® in Patients With Heart Failure

Clinical Trial Summary

This is a prospective, multi-center, open-label clinical trial intended to evaluate the safety and effectiveness of the MobiusHD® in patients with heart failure and reduced ejection fraction.

Clinical Trial Description

Subjects presenting with Class II, III or ambulatory IV heart failure with a left ventricular ejection fraction of ≤ 40% and NT-proBNP ≥ 400 will be considered for the study. Subjects who meet the initial screening requirements will undergo non-invasive imaging of the carotid anatomy to assess adequacy of the anatomy to allow placement of the MobiusHD device. Eligible subjects will receive an implant placed in the internal carotid artery. Following implantation of the device, subjects will be seen at 1 week, 1, 3, 6, 12, 18, and 24 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04590001
Study type Interventional
Source Vascular Dynamics, Inc.
Contact Lisa Director, Clinical Operations
Phone (949) 231-7602
Email lgreen@vasculardynamics.com
Status Recruiting
Phase N/A
Start date October 2, 2020
Completion date June 2026
View Details
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