NCT04590001 Effect of the MobiusHD® in Patients With Heart Failure
| NCT ID | NCT04590001 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vascular Dynamics, Inc. |
| Condition | Heart Failure With Reduced Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-10-02 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2020-10-02 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04590001 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure With Reduced Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04590001 currently recruiting?
Yes, NCT04590001 is actively recruiting participants. Contact the research team at lgreen@vasculardynamics.com for enrollment information.
Where is the NCT04590001 trial being conducted?
This trial is being conducted at Darlinghurst, Australia, Murdoch, Australia, London, Canada, Montreal, Canada and 11 additional locations.
Who is sponsoring the NCT04590001 clinical trial?
NCT04590001 is sponsored by Vascular Dynamics, Inc.. The trial plans to enroll 50 participants.
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