Effect of the MobiusHD® in Patients With Heart Failure

RECRUITING

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.

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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.

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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
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2020-10-02

    Primary completion: 2025-12-01

    Study completion finish: 2026-06-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT04590001

    Intervention or treatment

    DEVICE: MobiusHD

    Conditions

    • Heart Failure With Reduced Ejection Fraction

    Find a site

    Closest Location:

    Fiona Stanley Hospital

    Research sites nearby

    Select from list below to view details:

    • Fiona Stanley Hospital

      Murdoch, Western Australia, Australia

    • St. Vincent's Hospital

      Darlinghurst, Sydney, Australia

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    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/ArmIntervention/Treatment
    EXPERIMENTAL: MobiusHD
    • Each subject enrolled in the study will undergo implantation of the MobiusHD device.
    DEVICE: MobiusHD
    • The MobiusHD device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Change in New York Heart Association Heart Failure ClassChange in New York Heart Association Heart Failure Class between baseline and 3 months, 6 months, 12 months, 18 months and 24 months24 months
    Change in NT-proBNP blood test levelsChange in Amino-terminal prohormone of brain natriuretic peptide (NT-proBNP) between baseline and 3 months, 6 months, 12 months, 18 months, and 24 months24 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 distanceChange in 6MHW distance between baseline and 3 months, 6 months, 12 months, 18 months and 24 months24 months
    Change in cardiac function / structureChange 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 EventsIncidence and severity of adverse events and serious adverse events, including serious adverse cardiovascular and neurological events24 months
    Cardiovascular MortalityRate of cardiovascular mortality throughout the follow-up period will be reported.24 months
    Heart Failure HospitalizationsRate of heart failure hospitalizations throughout the follow-up period will be reported.24 months

    Secondary outcome

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    References

    Clinical Trials Gov: Effect of the MobiusHD® in Patients With Heart Failure

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