Heart Failure With Reduced Ejection FractionHF-FIMNCT04590001
Effect of the MobiusHD® in Patients With Heart Failure
A study testing MobiusHD in people with Heart Failure With Reduced Ejection Fraction, run by Vascular Dynamics, Inc. at 17 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- MobiusHD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 17 sitesin 5 countries
- Study dates
- 2 Oct 2020to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or above
- Currently NYHA Class II, III or ambulatory IV heart failure
- Left ventricular ejection fraction ≤ 40%
- NT-proBNP ≥ 400
- Prescribed optimally-tolerated, stable, Guideline Directed Medical Therapy (GDMT) per country specific guidelines for the treatment of heart failure for at least 4 weeks
- Six-minute hall walk (6MHW) distance of ≥ 150 m AND ≤ 400 m
- Deemed an acceptable candidate for the implant procedure by the investigator
Who cannot join
- Known or clinically suspected baroreflex failure or autonomic neuropathy
- Currently implanted with a barostimulator device
- Received cardiac resynchronization therapy (CRT) within six months of implantation
- Received a CardioMEMS device within three months of the screening visit
- History of any prior stroke with permanent neurologic defect or any prior intracranial bleed or other serious brain injury
- Body mass index > 45
Show all 9Show fewer
- Serum estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
- Presence of atherosclerotic plaque in the intended side for implantation as determined by carotid duplex
- 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
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
Germany7 sites, 7 recruiting
- Recruiting
Charité Universitätsmedizin Berlin
Berlin
Katharina Gille, katharina.gille@dhzc-charite.de
Mohammad Sherif, Prof. dr. med
- Recruiting
Heart Center, University Hospital Dresden
Dresden
Cecile Bosredon, cecile.bosredon1@tu-dresden.de
Axel Linke, Prof. dr. med
- Recruiting
CardioVascular Center - CVC Frankfurt
Frankfurt
Stefanie Schlimm, s.schlimm@cvcfrankfurt.de
Horst Sievert, Prof. dr. med
- Recruiting
Justus-Liebig-Universitat Giessen
Giessen
Anne Drewenka, anne.drewenka@innere.med.uni-giessen.de
Christian Hamm, Prof. dr med
- Recruiting
University of Saarlandes - Homburg
Homburg
Christina Koch, christina.koch@uks.edu
Felix Mahfoud, Prof. dr. med
- Recruiting
Krankenhaus der Barmherzigen Brüder Trier
Trier
Hannah Waschbuesch, h.waschbuesch@bbtgruppe.de
Jurgen Leick, Dr. med
- Recruiting
University Hospital Ulm
Ulm
Uta Dischristin, +4973150045250, Uta.Dichristin@uniklinik-ulm.de
Wolfgang Rottbauer, Prod. dr. med
Serbia4 sites, 4 recruiting
- Recruiting
Clinical Hospital Center Bežanijska Kosa, Belgrade
Belgrade
SN Danka Đurić, milanovic.nadabgd@gmail.com
Marija Zdravković, Prof. dr.
- Recruiting
Institut for Cardiovascular Disease Dedinje, Belgrade
Belgrade
Milica Dragićević Antonić, Dr., +3818638025, milicadragicevic@yahoo.com
Dragana Košević, Dr.
- Recruiting
Institute for Cardiovascular Disease of Vojvodina
Kamenitz
Milovan Petrovic, MD
Milovan Petrovic, MD
- Recruiting
University Clinical Center, Kragujevac
Kragujevac
Rada Vučić, +381631123610, rada.vucic@gmail.com
Miodrag Srećković, Prof. dr.
Australia2 sites, 2 recruiting
- Recruiting
St. Vincent's Hospital
Darlinghurst, Sydney, NSW 2010
Erika O'Dea, erika.odea@svha.org.au
David Muller, MD
- Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Gillian Tulloch, gillian.tulloch@health.wa.gov.au
Amit Shah, MD
Canada2 sites, 2 recruiting
- Recruiting
London Health Science Center
London, Ontario, N6A 5A5
Heather Hern, 5196858500, heather.hern@lhsc.on.ca
Stuart Smith, MD
- Recruiting
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Helene Brown, helene.brown@icm-mhi.org
Anique Ducharme, MD
Georgia2 sites
- Completed
Helsicore Ltd "Israeli-Georgian Medical Research Clinic Helsicore"
Tbilisi
- Completed
Tbilisi Heart and Vascular Center
Tbilisi
About this study
Official title: A Feasibility Study Exploring the Effect of the MobiusHD® in Patients With Heart Failure
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.
Read the 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.
- Being tested
- MobiusHD
- Keywords
- Heart Failure, Mobius HD
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MobiusHDDevice
The MobiusHD device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.
| Study group | Role | What they receive |
|---|---|---|
| MobiusHD | Experimental | Each subject enrolled in the study will undergo implantation of the MobiusHD device. Receives: Device: MobiusHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 24 months
Change in 6MHW distance
Change in 6MHW distance between baseline and 3 months, 6 months, 12 months, 18 months and 24 months
Measured: 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.
Measured: 24 months
Adverse Events
Incidence and severity of adverse events and serious adverse events, including serious adverse cardiovascular and neurological events
Measured: 24 months
Cardiovascular Mortality
Rate of cardiovascular mortality throughout the follow-up period will be reported.
Measured: 24 months
Heart Failure Hospitalizations
Rate of heart failure hospitalizations throughout the follow-up period will be reported.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start2 Oct 2020
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vascular Dynamics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590001
- Sponsor's protocol ID
- CRD0593 0594 0595 0596 0610
- Acronym
- HF-FIM
- Status last verified
- Feb 2024
- First submitted
- 5 Oct 2020
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Exploring the Effect of the MobiusHD® in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT04590001
- Acronym / sponsor ID
- HF-FIM / CRD0593 0594 0595 0596 0610
- Keywords
- Heart Failure, Mobius HD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Vascular Dynamics, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MobiusHD | Experimental | Device: MobiusHDEach subject enrolled in the study will undergo implantation of the MobiusHD device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or above
- Currently NYHA Class II, III or ambulatory IV heart failure
- Left ventricular ejection fraction ≤ 40%
- NT-proBNP ≥ 400
- Prescribed optimally-tolerated, stable, Guideline Directed Medical Therapy (GDMT) per country specific guidelines for the treatment of heart failure for at least 4 weeks
Key exclusion criteria (9 listed)
- Known or clinically suspected baroreflex failure or autonomic neuropathy
- Currently implanted with a barostimulator device
- Received cardiac resynchronization therapy (CRT) within six months of implantation
- Received a CardioMEMS device within three months of the screening visit
- History of any prior stroke with permanent neurologic defect or any prior intracranial bleed or other serious brain injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MobiusHDThe MobiusHD device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach. | Device | MobiusHD |
Primary outcome
Change in New York Heart Association Heart Failure Class
Time frame: 24 months
Change in New York Heart Association Heart Failure Class between baseline and 3 months, 6 months, 12 months, 18 months and 24 months
Change in NT-proBNP blood test levels
Time frame: 24 months
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
Change in QoL as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EQ-5D Questionnaire.
Time frame: 24 months
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.
Change in 6MHW distance
Time frame: 24 months
Change in 6MHW distance between baseline and 3 months, 6 months, 12 months, 18 months and 24 months
Change in cardiac function / structure
Time frame: 24 months
Change will be evaluated using echocardiogram measured left ventricular ejection fraction, LV end diastolic volume, left atrial volume index, and severity of mitral regurgitation.
Adverse Events
Time frame: 24 months
Incidence and severity of adverse events and serious adverse events, including serious adverse cardiovascular and neurological events
Cardiovascular Mortality
Time frame: 24 months
Rate of cardiovascular mortality throughout the follow-up period will be reported.
Heart Failure Hospitalizations
Time frame: 24 months
Rate of heart failure hospitalizations throughout the follow-up period will be reported.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MobiusHD in people with Heart Failure With Reduced Ejection Fraction, run by Vascular Dynamics, Inc. at 17 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, Serbia, Australia, Canada, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Director, Clinical Operations ((949) 231-7602, lgreen@vasculardynamics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in New York Heart Association Heart Failure Class (time frame: 24 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.