Actively Recruiting
Effect of the MobiusHD® in Patients With Heart Failure
Led by Vascular Dynamics, Inc. · Updated on 2024-02-14
50
Participants Needed
17
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of the MobiusHD® in Patients With Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or above
- Currently New York Heart Association Class II, III or ambulatory IV heart failure
- Left ventricular ejection fraction 40% or less
- NT-proBNP 400 or higher
- Prescribed stable, optimally-tolerated, Guideline Directed Medical Therapy for at least 4 weeks
- Six-minute hall walk distance between 150 and 400 meters
- Considered suitable candidate for the implant procedure by the investigator
You will not qualify if you...
- Known or suspected baroreflex failure or autonomic neuropathy
- Currently implanted with a barostimulator device
- Received cardiac resynchronization therapy within 6 months
- Received a CardioMEMS device within 3 months of screening
- History of stroke with permanent neurological defect or serious brain injury
- Body mass index over 45
- Serum estimated glomerular filtration rate below 30 mL/min/1.73 m2
- Presence of atherosclerotic plaque in intended implant side
- Internal carotid artery lumen diameter less than 5.0 mm or greater than 11.75 mm at implant site, or other vessel restrictions preventing safe implant placement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
St. Vincent's Hospital
Darlinghurst, Sydney, Australia, NSW 2010
Actively Recruiting
2
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
3
London Health Science Center
London, Ontario, Canada, N6A 5A5
Actively Recruiting
4
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Actively Recruiting
5
Helsicore Ltd "Israeli-Georgian Medical Research Clinic Helsicore"
Tbilisi, Georgia
Completed
6
Tbilisi Heart and Vascular Center
Tbilisi, Georgia
Completed
7
Charité Universitätsmedizin Berlin
Berlin, Germany
Actively Recruiting
8
Heart Center, University Hospital Dresden
Dresden, Germany
Actively Recruiting
9
CardioVascular Center - CVC Frankfurt
Frankfurt, Germany
Actively Recruiting
10
Justus-Liebig-Universitat Giessen
Giessen, Germany
Actively Recruiting
11
University of Saarlandes - Homburg
Homburg, Germany
Actively Recruiting
12
Krankenhaus der Barmherzigen Brüder Trier
Trier, Germany
Actively Recruiting
13
University Hospital Ulm
Ulm, Germany
Actively Recruiting
14
Clinical Hospital Center Bežanijska Kosa, Belgrade
Belgrade, Serbia
Actively Recruiting
15
Institut for Cardiovascular Disease Dedinje, Belgrade
Belgrade, Serbia
Actively Recruiting
16
Institute for Cardiovascular Disease of Vojvodina
Kamenitz, Serbia
Actively Recruiting
17
University Clinical Center, Kragujevac
Kragujevac, Serbia
Actively Recruiting
Research Team
L
Lisa Director, Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here