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Device

MobiusHD® for Heart Failure (HF-FIM Trial)

N/A
Recruiting
Research Sponsored by Vascular Dynamics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Left ventricular ejection fraction ≤ 40%
Age 18 years or above
Must not have
Presence of atherosclerotic plaque in the intended side for implantation as determined by carotid duplex
History of any prior stroke with permanent neurologic defect or any prior intracranial bleed or other serious brain injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test how safe and effective the MobiusHD® is for patients with heart failure and reduced ejection fraction.

Who is the study for?
This trial is for adults over 18 with heart failure who have a left ventricular ejection fraction of 40% or less. They should be in NYHA Class II or III, have NT-proBNP levels ≥ 400, and can walk between 150 to 400 meters in six minutes. Participants must not be severely overweight, have certain neurological conditions, recently received specific heart treatments, or have severe kidney issues.
What is being tested?
The MobiusHD® device's safety and effectiveness are being tested on patients with heart failure and reduced ejection fraction. This study is forward-looking (prospective), involves multiple centers, and does not conceal the treatment (open-label).
What are the potential side effects?
While the side effects are not explicitly listed here, similar devices may cause discomfort at the implant site, blood pressure changes due to baroreflex activation, potential nerve damage risks during implantation procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart's pumping ability is reduced.
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I am 18 years old or older.
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I can walk between 150 and 400 meters in six minutes.
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I have moderate heart failure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have plaque in my arteries where a device might be placed.
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I have had a stroke or serious brain injury that left me with lasting effects.
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My artery size or shape may not safely allow for an implant where planned.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events
Cardiovascular Mortality
Change in 6MHW distance
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: MobiusHDExperimental Treatment1 Intervention
Each subject enrolled in the study will undergo implantation of the MobiusHD device.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MobiusHD
2013
N/A
~30

Find a Location

Who is running the clinical trial?

Vascular Dynamics, Inc.Lead Sponsor
6 Previous Clinical Trials
551 Total Patients Enrolled

Media Library

MobiusHD (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04590001 — N/A
Heart Failure Research Study Groups: MobiusHD
Heart Failure Clinical Trial 2023: MobiusHD Highlights & Side Effects. Trial Name: NCT04590001 — N/A
MobiusHD (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04590001 — N/A
~9 spots leftby Dec 2025
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