Clinical trial NCT04590001: Effect of the MobiusHD® in Patients With Heart Failure
Official title: A Feasibility Study Exploring the Effect of the MobiusHD® in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: Heart Failure
Mobius HD
Lead sponsor: Vascular Dynamics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in New York Heart Association Heart Failure Class
timeFrame: 24 months
measure: Change in NT-proBNP blood test levels
timeFrame: 24 months
measure: Change in QoL as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EQ-5D Questionnaire.
timeFrame: 24 months
measure: Change in 6MHW distance
timeFrame: 24 months
measure: Change in cardiac function / structure
timeFrame: 24 months
measure: Adverse Events
timeFrame: 24 months
measure: Cardiovascular Mortality
timeFrame: 24 months
measure: Heart Failure Hospitalizations
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital
state: Sydney
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: London
country: Canada
facility: London Health Science Center
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Tbilisi
country: Georgia
facility: Helsicore Ltd "Israeli-Georgian Medical Research Clinic Helsicore"
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Center
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Dresden
country: Germany
facility: Heart Center, University Hospital Dresden
city: Frankfurt
country: Germany
facility: CardioVascular Center - CVC Frankfurt
city: Gießen
country: Germany
facility: Justus-Liebig-Universitat Giessen
city: Homburg
country: Germany
facility: University of Saarlandes - Homburg
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Trier
city: Ulm
country: Germany
facility: University Hospital Ulm
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Bežanijska Kosa, Belgrade
city: Belgrade
country: Serbia
facility: Institut for Cardiovascular Disease Dedinje, Belgrade
city: Kragujevac
country: Serbia
facility: University Clinical Center, Kragujevac
city: Sremska Kamenica
country: Serbia
facility: Institute for Cardiovascular Disease of Vojvodina
Study officials:
References: