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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04590001
Registration number
NCT04590001
Ethics application status
Date submitted
5/10/2020
Date registered
19/10/2020
Date last updated
14/02/2024
Titles & IDs
Public title
Effect of the MobiusHD® in Patients With Heart Failure
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Scientific title
A Feasibility Study Exploring the Effect of the MobiusHD® in Patients With Heart Failure
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Secondary ID [1]
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CRD0593 0594 0595 0596 0610
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Universal Trial Number (UTN)
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Trial acronym
HF-FIM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure With Reduced Ejection Fraction
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - MobiusHD
Experimental: MobiusHD - Each subject enrolled in the study will undergo implantation of the MobiusHD device.
Treatment: Devices: MobiusHD
The MobiusHD device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in New York Heart Association Heart Failure Class
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Assessment method [1]
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Change in New York Heart Association Heart Failure Class between baseline and 3 months, 6 months, 12 months, 18 months and 24 months
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Timepoint [1]
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24 months
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Primary outcome [2]
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Change in NT-proBNP blood test levels
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Assessment method [2]
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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
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Timepoint [2]
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24 months
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Primary outcome [3]
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Change in QoL as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EQ-5D Questionnaire.
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Assessment method [3]
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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.
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Timepoint [3]
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24 months
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Primary outcome [4]
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Change in 6MHW distance
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Assessment method [4]
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Change in 6MHW distance between baseline and 3 months, 6 months, 12 months, 18 months and 24 months
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Timepoint [4]
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24 months
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Primary outcome [5]
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Change in cardiac function / structure
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Assessment method [5]
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Change will be evaluated using echocardiogram measured left ventricular ejection fraction, LV end diastolic volume, left atrial volume index, and severity of mitral regurgitation.
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Timepoint [5]
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24 months
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Primary outcome [6]
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Adverse Events
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Assessment method [6]
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Incidence and severity of adverse events and serious adverse events, including serious adverse cardiovascular and neurological events
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Timepoint [6]
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24 months
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Primary outcome [7]
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Cardiovascular Mortality
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Assessment method [7]
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Rate of cardiovascular mortality throughout the follow-up period will be reported.
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Timepoint [7]
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24 months
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Primary outcome [8]
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Heart Failure Hospitalizations
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Assessment method [8]
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Rate of heart failure hospitalizations throughout the follow-up period will be reported.
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Timepoint [8]
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24 months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/10/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2026
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SydneyWA
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Recruitment hospital [1]
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St. Vincent's Hospital - Darlinghurst
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Recruitment hospital [2]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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NSW 2010 - Darlinghurst
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Recruitment postcode(s) [2]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Ontario
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Country [2]
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Canada
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State/province [2]
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Quebec
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Country [3]
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Georgia
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State/province [3]
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Tbilisi
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Country [4]
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Germany
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State/province [4]
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Berlin
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Country [5]
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Germany
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State/province [5]
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Dresden
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Country [6]
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Germany
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State/province [6]
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Frankfurt
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Country [7]
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Germany
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State/province [7]
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Gießen
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Country [8]
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Germany
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State/province [8]
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Homburg
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Country [9]
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Germany
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State/province [9]
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Trier
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Country [10]
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Germany
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State/province [10]
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Ulm
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Country [11]
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Serbia
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State/province [11]
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Belgrade
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Country [12]
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Serbia
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State/province [12]
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Kragujevac
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Country [13]
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Serbia
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State/province [13]
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Sremska Kamenica
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Vascular Dynamics, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04590001
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Lisa Director, Clinical Operations
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Address
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Country
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Phone
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(949) 231-7602
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04590001
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