MobiusHD® for Heart Failure

(HF-FIM Trial)

Recruiting at 14 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

Trial Summary

What is the purpose of this trial?

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.

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.

How is the MobiusHD treatment different from other heart failure treatments?

The MobiusHD treatment is unique because it involves a device that modifies the body's natural reflexes to help manage heart failure, unlike traditional drug therapies or other devices that focus on heart rhythm or pressure monitoring. ^{1 2 3 4 5}

Eligibility Criteria

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 am 18 years old or older.

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Concurrent Assessment of the CardioMEMS HF System and HeartLogic HF Diagnostic: A Retrospective Case Series. [2022]

2. Poland pubmed.ncbi.nlm.nih.gov

Vagus nerve stimulation: A new approach to reduce heart failure. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Pacing Therapies in Congestive Heart Failure II study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Vagal stimulation in heart failure. [2021]

5. England 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. [2013]