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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04590001




Registration number
NCT04590001
Ethics application status
Date submitted
5/10/2020
Date registered
19/10/2020
Date last updated
9/02/2021

Titles & IDs
Public title
Effect of the MobiusHD® in Patients With Heart Failure
Scientific title
A Feasibility Study Exploring the Effect of the MobiusHD® in Patients With Heart Failure
Secondary ID [1] 0 0
CRD0593, CRD0594, CRD0595
Universal Trial Number (UTN)
Trial acronym
HF-FIM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure With Reduced Ejection Fraction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
24 months
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
24 months
Primary outcome [4] 0 0
Change in 6MHW distance - Change in 6MHW distance between baseline and 3 months, 6 months, 12 months, 18 months and 24 months
Timepoint [4] 0 0
24 months
Primary outcome [5] 0 0
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.
Timepoint [5] 0 0
6 months
Primary outcome [6] 0 0
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.
Timepoint [6] 0 0
24 months
Primary outcome [7] 0 0
Adverse Events - Incidence and severity of adverse events and serious adverse events, including serious adverse cardiovascular and neurological events
Timepoint [7] 0 0
24 months
Primary outcome [8] 0 0
Cardiovascular Mortality - Rate of cardiovascular mortality throughout the follow-up period will be reported.
Timepoint [8] 0 0
24 months
Primary outcome [9] 0 0
Heart Failure Hospitalizations - Rate of heart failure hospitalizations throughout the follow-up period will be reported.
Timepoint [9] 0 0
24 months

Eligibility
Key inclusion criteria
1. Age 18 years or above

2. Currently NYHA Class II or III 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

8. 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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 <4.5 mm or >12.5 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
GenesisCare Bundaberg - Bundaberg
Recruitment hospital [2] 0 0
GenesisCare Greenslopes - Greenslopes
Recruitment hospital [3] 0 0
GenesisCare Leabrook - Adelaide
Recruitment hospital [4] 0 0
GenesisCare Murdoch - Murdoch
Recruitment postcode(s) [1] 0 0
4670 - Bundaberg
Recruitment postcode(s) [2] 0 0
4120 - Greenslopes
Recruitment postcode(s) [3] 0 0
5068 - Adelaide
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
Georgia
State/province [1] 0 0
Tbilisi

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vascular Dynamics, Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT04590001
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sr. Director, Clinical
Address 0 0
Country 0 0
Phone 0 0
(949) 942-1640
Fax 0 0
Email 0 0
rnangia@vasculardynamics.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04590001