Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
Heart Failure, Mobius HD
Brief summary
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.
Detailed description
Subjects presenting with Class II, III or ambulatory IV heart failure with a left ventricular ejection fraction of ≤ 40% and NT-proBNP ≥ 400 will be considered for the study. Subjects who meet the initial screening requirements will undergo non-invasive imaging of the carotid anatomy to assess adequacy of the anatomy to allow placement of the MobiusHD device. Eligible subjects will receive an implant placed in the internal carotid artery. Following implantation of the device, subjects will be seen at 1 week, 1, 3, 6, 12, 18, and 24 months.
Interventions
DEVICEMobiusHD
The MobiusHD device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.
Sponsors
Vascular Dynamics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in New York Heart Association Heart Failure Class | 24 months | Change in New York Heart Association Heart Failure Class between baseline and 3 months, 6 months, 12 months, 18 months and 24 months |
| Change in NT-proBNP blood test levels | 24 months | Change in Amino-terminal prohormone of brain natriuretic peptide (NT-proBNP) between baseline and 3 months, 6 months, 12 months, 18 months, and 24 months |
| Change in QoL as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EQ-5D Questionnaire. | 24 months | Change in QoL measures between baseline and 3 months, 6 months, 12 months, 18 months, and 24 months will be measured. The KCCQ is used to measure the effect of heart failure on quality of life with a lower score indicating a worsening quality of life. The EQ-5D Questionnaire is a general measure of overall health with a lower score indicating a better overall health perception. |
| Change in 6MHW distance | 24 months | Change in 6MHW distance between baseline and 3 months, 6 months, 12 months, 18 months and 24 months |
| Change in cardiac function / structure | 24 months | Change will be evaluated using echocardiogram measured left ventricular ejection fraction, LV end diastolic volume, left atrial volume index, and severity of mitral regurgitation. |
| Adverse Events | 24 months | Incidence and severity of adverse events and serious adverse events, including serious adverse cardiovascular and neurological events |
| Cardiovascular Mortality | 24 months | Rate of cardiovascular mortality throughout the follow-up period will be reported. |
| Heart Failure Hospitalizations | 24 months | Rate of heart failure hospitalizations throughout the follow-up period will be reported. |
Countries
Australia, Canada, Georgia, Germany, Serbia
Contacts
Primary ContactLisa Director, Clinical Operations
Outcome results
None listed