Effect of the MobiusHD® in Patients With Heart Failure (HF-FIM)

  • STATUS
    Recruiting
  • End date
    Dec 13, 2023
  • participants needed
    40
  • sponsor
    Vascular Dynamics, Inc.
Updated on 13 May 2022

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.

Description

Subjects presenting with Class II or III 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.

Details
Condition Heart Failure With Reduced Ejection Fraction
Treatment MobiusHD
Clinical Study IdentifierNCT04590001
SponsorVascular Dynamics, Inc.
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years or above
Currently NYHA Class II or III 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
Adequacy of the carotid anatomy for treatment with the MobiusHD implant based on non-invasive carotid duplex and CTA/MRA imaging, and invasive carotid angiography

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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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