RecruitingNot ApplicableNCT04590001
Effect of the MobiusHD® in Patients With Heart Failure
A Feasibility Study Exploring the Effect of the MobiusHD® in Patients With Heart Failure
Sponsor
Vascular Dynamics, Inc.
Enrollment
50 participants
Start Date
Oct 2, 2020
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- 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
Exclusion Criteria9
- 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
- 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
Interventions
DEVICEMobiusHD
The MobiusHD device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.
Locations(17)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04590001
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