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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

TREATMENT

Phase

Trial ID

NCT04590001

Intervention or treatment

DEVICE: MobiusHD

Conditions

• Heart Failure With Reduced Ejection Fraction

Image related to Heart Failure With Reduced Ejection Fraction

Condition: Heart Failure With Reduced Ejection Fraction
DEVICE: MobiusHD
Murdoch, Western Australia, Australia and more
Sponsor: Vascular Dynamics, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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

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 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 Measure	Primary Outcome Description	Primary Outcome 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

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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