Effect of the MobiusHD® in Patients With Heart Failure
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Age 18 years or above
- Currently NYHA Class II, III or ambulatory IV heart failure
- Left ventricular ejection fraction ≤ 40%
- NT-proBNP ≥ 400
- Prescribed optimally-tolerated, stable, Guideline Directed Medical Therapy (GDMT) per country specific guidelines for the treatment of heart failure for at least 4 weeks
- Six-minute hall walk (6MHW) distance of ≥ 150 m AND ≤ 400 m
- Deemed an acceptable candidate for the implant procedure by the investigator
Exclusion criteria
- Known or clinically suspected baroreflex failure or autonomic neuropathy
- Currently implanted with a barostimulator device
- Received cardiac resynchronization therapy (CRT) within six months of implantation
- Received a CardioMEMS device within three months of the screening visit
- History of any prior stroke with permanent neurologic defect or any prior intracranial bleed or other serious brain injury
- Body mass index > 45
- Serum estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
- Presence of atherosclerotic plaque in the intended side for implantation as determined by carotid duplex
- 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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- NA
Study ID
NCT04590001
Intervention or treatment
DEVICE: MobiusHD
Conditions
- Heart Failure With Reduced Ejection Fraction
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
St. Vincent's Hospital
Select from list below to view details:
St. Vincent's Hospital
Darlinghurst, Sydney, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
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Who is running the clinical trial?
Vascular Dynamics, Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: MobiusHD
| Device: MobiusHD |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Change in New York Heart Association Heart Failure Class | Change in New York Heart Association Heart Failure Class between baseline and 3 months, 6 months, 12 months, 18 months and 24 months | 24 months |
| Change in NT-proBNP blood test levels | 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 | 24 months |
| Change in QoL as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EQ-5D Questionnaire. | 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. | 24 months |
| Change in 6MHW distance | Change in 6MHW distance between baseline and 3 months, 6 months, 12 months, 18 months and 24 months | 24 months |
| Change in cardiac function / structure | Change will be evaluated using echocardiogram measured left ventricular ejection fraction, LV end diastolic volume, left atrial volume index, and severity of mitral regurgitation. | 24 months |
| Adverse Events | Incidence and severity of adverse events and serious adverse events, including serious adverse cardiovascular and neurological events | 24 months |
| Cardiovascular Mortality | Rate of cardiovascular mortality throughout the follow-up period will be reported. | 24 months |
| Heart Failure Hospitalizations | Rate of heart failure hospitalizations throughout the follow-up period will be reported. | 24 months |
Secondary Outcome
References
Clinical Trials Gov: Effect of the MobiusHD® in Patients With Heart FailureOther trials to consider
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