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
Positive Initial HFrEF Findings
This clinical trial is designed to evaluate the safety and effectiveness of the MobiusHD device in patients suffering from heart failure with reduced ejection fraction.
Patients were successfully implanted with the MobiusHD device in pre-procedurally determined locations.
Quality of Life Scores
Progressive improvements in patient-reported health status scores using the Kansas City Cardiomyopathy Questionnaire (KCCQ) were found at 3, 6, and 12 months follow-up. An improvement of 16 points in the average KCCQ overall summary scores was found; this exceeds the minimum improvement of 5 points recognized as that required to show a clinically meaningful change.
6 Minute Walk Distance
The Six Minute Walk Distance (6MWD) is a standard measurement of exercise tolerance for heart failure patients. Progressive improvements in 6MWD were found for EVBA patients showing an average improvement of 98 meters in walk distance at 12 months follow-up, exceeding the minimum clinically meaningful change of 30 meters.
NYHA Class Change
All patients enrolled in the EVBA HF-FIH study were categorized as symptomatic NYHA (New York Heart Association) Class III as reported by their physicians. At 12 months follow-up, 14 of 21 (67%) patients were re-classified to a lower Class II category showing relief of many pre-procedural clinical symptoms.
%LVEF Improvement
Prior to treatment, study patients had an average %LVEF (left ventricular ejection fraction) of 34.9%. Following EVBA with the MobiusHD device and with maintained HF medication therapy, the average %LVEF was 40.4% at 12 months follow-up. These echocardiographic changes suggest reverse remodeling due to the EVBA treatment.
Reduction in NT-proBNP
Natriuretic peptide tests (NT-proBNP) provide an objective characterization of heart failure. Improvements indicated by reductions of 10-30% have been reported to be clinically meaningful changes. EVBA patients in this study showed a 28% reduction in the median of NT-proBNP from baseline to 12 months follow-up.
Clinical Trial Results
All patients were successfully implanted with the MobiusHD device in pre-procedurally determined locations
