Effect of the MobiusHD® in Patients With Heart Failure

Vascular Dynamics, Inc.50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure With Reduced Ejection Fraction

Interventions

MobiusHDDEVICE

The MobiusHD device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

St. Vincent's Hospital

Darlinghurst, Sydney, Australia

RECRUITING

Fiona Stanley Hospital

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: 24 months

Change in 6MHW distance

Change in 6MHW distance between baseline and 3 months, 6 months, 12 months, 18 months and 24 months

Time frame: 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.

Time frame: 24 months

Adverse Events

Incidence and severity of adverse events and serious adverse events, including serious adverse cardiovascular and neurological events

Time frame: 24 months

Cardiovascular Mortality

Central Contacts

Lisa Director, Clinical Operations

CONTACT

(949) 231-7602 lgreen@vasculardynamics.com

Data from ClinicalTrials.gov

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