A Feasibility Study Exploring the Effect of the MobiusHD® in Patients With Heart Failure (HF-FIM)
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- STATUS
- Recruiting
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- End date
- Dec 24, 2023
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- participants needed
- 40
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- sponsor
- Vascular Dynamics, Inc.
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.
Description
Subjects presenting with Class II or III 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.
Details
| Condition | Heart Failure With Reduced Ejection Fraction |
|---|---|
| Treatment | MobiusHD |
| Clinical Study Identifier | NCT04590001 |
| Sponsor | Vascular Dynamics, Inc. |
| Last Modified on | 24 October 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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