MobiusHD® for Heart Failure

(HF-FIM Trial)

Recruiting at 16 trial locations

Overseen By Lisa Director, Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vascular Dynamics, Inc.

Must be taking: Guideline directed therapy

Disqualifiers: Baroreflex failure, Stroke, BMI > 45, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 week

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called MobiusHD to determine its safety and effectiveness for people with heart failure and a reduced ejection fraction (a measure of how well the heart pumps blood). Participants will have the MobiusHD device implanted to help manage their condition. It suits those with ongoing heart failure symptoms who have been on stable heart failure medication for at least four weeks. As an unphased trial, this study allows patients to contribute to innovative research and potentially benefit from a novel treatment approach.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires that you are on stable, guideline-directed medical therapy for heart failure for at least 4 weeks before participating.

What prior data suggests that the MobiusHD device is safe for heart failure patients?

Research has shown that the MobiusHD device is safe for humans. In earlier studies, it helped people with heart failure and improved their quality of life. Another study confirmed the device's safety even after three years. These results suggest that patients generally tolerate the device well. Overall, existing evidence supports the safety of the MobiusHD for treating heart failure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional heart failure treatments that often involve medications or lifestyle changes, MobiusHD is an implantable device offering a novel approach. This device is designed to modulate nerve signals in the carotid artery, potentially improving heart function by altering how the body regulates blood pressure and heart rate. Researchers are excited because this mechanism directly targets the autonomic nervous system, offering a new pathway that could enhance heart failure management beyond current options.

What evidence suggests that the MobiusHD device is effective for heart failure?

Research has shown that the MobiusHD device, which participants in this trial will receive, could benefit heart failure patients with reduced ejection fraction. Studies have found that this device helps lower blood pressure, an important factor in managing heart failure. In one study, patients experienced a significant drop in blood pressure over three years. Another study showed positive results after two years, supporting its potential benefits for heart failure treatment. These findings suggest that MobiusHD might improve heart function and be safe for patients. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My heart's pumping ability is reduced.

Your NT-proBNP level is 400 or higher.

I can walk between 150 and 400 meters in six minutes.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Eligible subjects will receive an implant placed in the internal carotid artery

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Visits at 1 week, 1, 3, 6, 12, 18, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• MobiusHD

Trial Overview 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).

How Is the Trial Designed?

Group I: MobiusHD Experimental Treatment 1 Intervention

Each subject enrolled in the study will undergo implantation of the MobiusHD device.

MobiusHD is already approved in European Union, United States for the following indications:

Approved in European Union as MobiusHD for:

• Hypertension
• Heart failure with reduced ejection fraction

Approved in United States as MobiusHD for:

• Resistant hypertension
• Heart failure with reduced ejection fraction (under investigation)

Who Is Running the Clinical Trial?

Vascular Dynamics, Inc.

Lead Sponsor

Trials

7

Recruited

600+

Published Research Related to This Trial

In a study of 7 heart failure patients monitored for over a year, the HeartLogic index (HLI) alerts were associated with a significant increase in pulmonary artery diastolic pressures (PADP), indicating potential worsening of heart failure during these alert periods.

Although the correlation between PADP and HLI was weak, the findings suggest that HLI alerts could be useful for predicting increases in PADP, which may help in optimizing heart failure management and preventing hospitalizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concurrent Assessment of the CardioMEMS HF System and HeartLogic HF Diagnostic: A Retrospective Case Series. Chilcote, JL., Summers, RP., Vaz, DG., et al.[2022]

Ventricular resynchronization therapy (VRT) is being studied as a promising treatment for patients with advanced heart failure, showing acute hemodynamic benefits, but long-term data is still limited.

The ongoing PATH-CHF II study aims to evaluate the effects of optimized univentricular pacing on functional capacity and quality of life in 64 patients, focusing on different pacing sites and their impact on hemodynamic performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pacing Therapies in Congestive Heart Failure II study. Stellbrink, C., Auricchio, A., Butter, C., et al.[2019]

A variety of new devices for treating heart failure, such as cardiac contractility modulation and spinal cord stimulation, are being increasingly utilized in clinical settings, particularly for patients with advanced heart failure (NYHA Classes III and IV).

These devices aim to enhance treatment options alongside standard medical therapies, providing additional strategies for managing heart failure in patients with narrow QRS complexes, who make up a significant portion of the heart failure population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New devices in heart failure: an European Heart Rhythm Association report: developed by the European Heart Rhythm Association; endorsed by the Heart Failure Association. Kuck, KH., Bordachar, P., Borggrefe, M., et al.[2013]

Vagus nerve stimulation (VNS) has shown promise in treating advanced heart failure (HF) by significantly improving symptoms, increasing left ventricular ejection fraction, and reducing ventricular volumes over a 12-month follow-up period.

The initial study demonstrated the feasibility and safety of VNS in HF patients, suggesting that enhancing parasympathetic activity could be a new therapeutic approach for those already on optimal medical therapy, although further research with larger trials is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vagus nerve stimulation: A new approach to reduce heart failure. Klein, HU., Ferrari, GM.[2022]

Chronic vagal stimulation has been shown to be safe and well-tolerated in a pilot study of 32 patients with chronic heart failure, leading to improvements in quality of life and exercise capacity as measured by the 6-minute walk test.

The pilot study also demonstrated objective cardiac improvements, including reduced left ventricular systolic volumes and enhanced left ventricular ejection fraction, suggesting that vagal stimulation may positively impact heart function in heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vagal stimulation in heart failure. De Ferrari, GM.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10242580/

Endovascular Baroreflex Amplification With the MobiusHD ... We hypothesized that in this first-in-human feasibility study, EVBA with the MobiusHD system would be safe and associated with favorable impact on patient- ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04590001

Effect of the MobiusHD® in Patients With Heart Failure 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1936879821021671

3-Year Results From the CALM-FIM Study EVBA with the MobiusHD was effective in reducing BP at 3-year follow-up and appears to have an acceptable safety profile in patients with uncomplicated ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39818666/

24-Month Outcomes of Endovascular Baroreflex ... 24-Month Outcomes of Endovascular Baroreflex Amplification With the MobiusHD Device in Heart Failure With Reduced Ejection Fraction.

5. biospace.com biospace.com/two-year-study-data-for-evba-procedure-with-unique-mobiushd-device-presented-at-technology-and-heart-failure-therapeutics-meeting

Two-Year Study Data for EVBA Procedure with Unique ... Vascular Dynamics, Inc. (VDI) announced that two-year results from a study assessing its MobiusHD device to treat patients with chronic ...

6. jacc.org jacc.org/doi/10.1016/j.jchf.2023.07.002

Device Interventions for Heart Failure Data at 12 months follow-up showed consistent efficacy and safety results with greater effect when diaphragmatic synchronization was >80% of ...