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

Vascular Dynamics

Status: Enrolling

Conditions: Heart Failure With Reduced Ejection Fraction

Treatments: Device: MobiusHD

Study type: Interventional

Funder types: Industry

Identifiers

NCT04590001

CRD0593 0594 0595 0596 0610

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

MobiusHD

Experimental group

Description:

Each subject enrolled in the study will undergo implantation of the MobiusHD device.

Treatment:

Device: MobiusHD