Clinical Trials
A Feasibility Study Exploring the Effect of the
MobiusHD Device in Patients with Heart Failure
Study Design
- Prospective, open-label clinical trial
- Subjects to be seen at the following intervals: 1 week, 1, 3, 6, 12, 18, and 24 months
Key Eligibility Criteria
- Suitable carotid artery anatomy
- Stable Guideline Directed Medical Therapy (GDMT)
- LVEF ≤ 40%
- NYHA Class III
- 6MWD distance of 150 to 400m
- NT-proBNP ≥ 400 pg/mL
Confirmatory Evidence (n=21)
- All patients were successfully implanted with the MobiusHD device in pre-procedurally determined locations
- Initial evidence through 12 months FU shows favorable effects on cardiac function and clinical profile
- Improved quality of life (KCCQ OSS)
- Increased exercise tolerance 6MWD
- Improved NYHA class