Using MobiusHD® to treat heart failure

A Feasibility Study Exploring the Effect of the MobiusHD® in Patients With Heart Failure

This study is testing if the MobiusHD® device can safely help people with heart failure feel better by placing it in their carotid artery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vascular Dynamics, Inc. (industry)
• Locations: 17 sites (Darlinghurst, Sydney and 16 other locations)
• Trial ID: NCT04590001 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of the MobiusHD® device in patients suffering from heart failure with reduced ejection fraction. Participants with Class II, III, or ambulatory IV heart failure and a left ventricular ejection fraction of 40% or less will undergo non-invasive imaging to assess their carotid anatomy for device placement. Eligible patients will receive the MobiusHD implant in the internal carotid artery and will be monitored at various intervals over a two-year period to assess outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with NYHA Class II, III, or ambulatory IV heart failure and specific ejection fraction and NT-proBNP levels.

Not a fit: Patients with baroreflex failure, autonomic neuropathy, or those who have had recent cardiac interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve heart failure management and patient quality of life.

How similar studies have performed: While the MobiusHD device is a novel approach, similar interventions in heart failure management have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

1. Age 18 years or above
2. Currently NYHA Class II, III or ambulatory IV heart failure
3. Left ventricular ejection fraction ≤ 40%
4. NT-proBNP ≥ 400
5. Prescribed optimally-tolerated, stable, Guideline Directed Medical Therapy (GDMT) per country specific guidelines for the treatment of heart failure for at least 4 weeks
6. Six-minute hall walk (6MHW) distance of ≥ 150 m AND ≤ 400 m
7. Deemed an acceptable candidate for the implant procedure by the investigator

Exclusion Criteria:

1. Known or clinically suspected baroreflex failure or autonomic neuropathy
2. Currently implanted with a barostimulator device
3. Received cardiac resynchronization therapy (CRT) within six months of implantation
4. Received a CardioMEMS device within three months of the screening visit
5. History of any prior stroke with permanent neurologic defect or any prior intracranial bleed or other serious brain injury
6. Body mass index \> 45
7. Serum estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2
8. Presence of atherosclerotic plaque in the intended side for implantation as determined by carotid duplex
9. Internal ICA lumen diameters \<5.0 mm or \>11.75 mm within the planned location of the implant placement, or evidence of landing zone restrictions, such as inadequate length, vessel tapering, and/or vessel curvature that would preclude safe placement of the implant

Where this trial is running

Darlinghurst, Sydney and 16 other locations

• St. Vincent's Hospital — Darlinghurst, Sydney, Australia (RECRUITING)
• Fiona Stanley Hospital — Murdoch, Western Australia, Australia (RECRUITING)
• London Health Science Center — London, Ontario, Canada (RECRUITING)
• Montreal Heart Institute — Montreal, Quebec, Canada (RECRUITING)
• Helsicore Ltd "Israeli-Georgian Medical Research Clinic Helsicore" — Tbilisi, Georgia (COMPLETED)
• Tbilisi Heart and Vascular Center — Tbilisi, Georgia (COMPLETED)
• Charité Universitätsmedizin Berlin — Berlin, Germany (RECRUITING)
• Heart Center, University Hospital Dresden — Dresden, Germany (RECRUITING)
• CardioVascular Center - CVC Frankfurt — Frankfurt, Germany (RECRUITING)
• Justus-Liebig-Universitat Giessen — Giessen, Germany (RECRUITING)
• University of Saarlandes - Homburg — Homburg, Germany (RECRUITING)
• Krankenhaus der Barmherzigen Brüder Trier — Trier, Germany (RECRUITING)
• University Hospital Ulm — Ulm, Germany (RECRUITING)
• Clinical Hospital Center Bežanijska Kosa, Belgrade — Belgrade, Serbia (RECRUITING)
• Institut for Cardiovascular Disease Dedinje, Belgrade — Belgrade, Serbia (RECRUITING)
• Institute for Cardiovascular Disease of Vojvodina — Kamenitz, Serbia (RECRUITING)
• University Clinical Center, Kragujevac — Kragujevac, Serbia (RECRUITING)

Study contacts

• Study coordinator: Lisa Director, Clinical Operations

Conditions: Heart Failure With Reduced Ejection Fraction, Heart Failure, Mobius HD