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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
HF-FIM Trial 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.Check my eligibility
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).See study design
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.
HF-FIM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart's pumping ability is reduced.
Select...
I am 18 years old or older.
Select...
I can walk between 150 and 400 meters in six minutes.
Select...
I have moderate heart failure.
HF-FIM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events
Cardiovascular Mortality
Change in 6MHW distance
+5 moreHF-FIM 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have plaque in my arteries where a device might be placed.Your kidney function, measured by eGFR, is very low.You currently have a barostimulator device implanted.I received a heart pacing device within the last 6 months.You have had a CardioMEMS device implanted within the last three months before the screening visit.My heart's pumping ability is reduced.I have had a stroke or serious brain injury that left me with lasting effects.Your NT-proBNP level is 400 or higher.I am 18 years old or older.I can walk between 150 and 400 meters in six minutes.You have a very high body mass index.I have been on a stable heart failure treatment as per guidelines for over 4 weeks.My artery size or shape may not safely allow for an implant where planned.You have a known or suspected problem with your body's ability to regulate blood pressure or nervous system function.I have moderate heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: MobiusHD
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do you currently have any openings for participation in this experiment?
"Affirmative. The clinicaltrials.gov registry indicates that the trial, which had its origin on October 2nd 2020, is seeking applicants. Thus far 40 individuals have been enrolled from two distinct medical centres."
Answered by AI
What is the cut-off for admission to this research endeavor?
"Affirmative. The clinicaltrials.gov data confirms that this experimental trial, which was posted on October 2nd 2020 and updated lastly on October 10th 2022 is actively recruiting patients from two different centers with a total of 40 participants needed for the study."
Answered by AI
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