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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
A Feasibility Study Exploring the Effect of the MobiusHD® in Patients With Heart Failure
Secondary ID [1] 0 0
CRD0593 0594 0595 0596 0610
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
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
Change in NT-proBNP blood test levels
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.
Timepoint [3] 0 0
24 months
Primary outcome [4] 0 0
Change in 6MHW distance
Timepoint [4] 0 0
24 months
Primary outcome [5] 0 0
Change in cardiac function / structure
Timepoint [5] 0 0
24 months
Primary outcome [6] 0 0
Adverse Events
Timepoint [6] 0 0
24 months
Primary outcome [7] 0 0
Cardiovascular Mortality
Timepoint [7] 0 0
24 months
Primary outcome [8] 0 0
Heart Failure Hospitalizations
Timepoint [8] 0 0
24 months

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
Minimum age
18 Years
Maximum age
No limit
Sex
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 <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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
2/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SydneyWA
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
NSW 2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
Georgia
State/province [3] 0 0
Tbilisi
Country [4] 0 0
Germany
State/province [4] 0 0
Berlin
Country [5] 0 0
Germany
State/province [5] 0 0
Dresden
Country [6] 0 0
Germany
State/province [6] 0 0
Frankfurt
Country [7] 0 0
Germany
State/province [7] 0 0
Gießen
Country [8] 0 0
Germany
State/province [8] 0 0
Homburg
Country [9] 0 0
Germany
State/province [9] 0 0
Trier
Country [10] 0 0
Germany
State/province [10] 0 0
Ulm
Country [11] 0 0
Serbia
State/province [11] 0 0
Belgrade
Country [12] 0 0
Serbia
State/province [12] 0 0
Kragujevac
Country [13] 0 0
Serbia
State/province [13] 0 0
Sremska Kamenica

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/study/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
Lisa Director, Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
(949) 231-7602
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

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