Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2020-10-02
2026-06-30
Brief Summary
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Detailed Description
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Following implantation of the device, subjects will be seen at 1 week, 1, 3, 6, 12, 18, and 24 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MobiusHD
Each subject enrolled in the study will undergo implantation of the MobiusHD device.
MobiusHD
The MobiusHD device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.
Interventions
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MobiusHD
The MobiusHD device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Vascular Dynamics, Inc.
INDUSTRY
Responsible Party
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Locations
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St. Vincent's Hospital
Darlinghurst, Sydney, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
London Health Science Center
London, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Helsicore Ltd "Israeli-Georgian Medical Research Clinic Helsicore"
Tbilisi, , Georgia
Tbilisi Heart and Vascular Center
Tbilisi, , Georgia
Charité Universitätsmedizin Berlin
Berlin, , Germany
Heart Center, University Hospital Dresden
Dresden, , Germany
CardioVascular Center - CVC Frankfurt
Frankfurt, , Germany
Justus-Liebig-Universitat Giessen
Giessen, , Germany
University of Saarlandes - Homburg
Homburg, , Germany
Krankenhaus der Barmherzigen Brüder Trier
Trier, , Germany
University Hospital Ulm
Ulm, , Germany
Clinical Hospital Center Bežanijska Kosa, Belgrade
Belgrade, , Serbia
Institut for Cardiovascular Disease Dedinje, Belgrade
Belgrade, , Serbia
Institute for Cardiovascular Disease of Vojvodina
Kamenitz, , Serbia
University Clinical Center, Kragujevac
Kragujevac, , Serbia
Countries
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Central Contacts
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Facility Contacts
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Milovan Petrovic, MD
Role: primary
Other Identifiers
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CRD0593 0594 0595 0596 0610
Identifier Type: -
Identifier Source: org_study_id
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