Trials / Recruiting
RecruitingNCT04590001
Effect of the MobiusHD® in Patients With Heart Failure
A Feasibility Study Exploring the Effect of the MobiusHD® in Patients With Heart Failure
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Vascular Dynamics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MobiusHD | The MobiusHD device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach. |
Timeline
- Start date
- 2020-10-02
- Primary completion
- 2025-12-01
- Completion
- 2026-06-01
- First posted
- 2020-10-19
- Last updated
- 2024-02-14
Locations
17 sites across 5 countries: Australia, Canada, Georgia, Germany, Serbia
Source: ClinicalTrials.gov record NCT04590001. Inclusion in this directory is not an endorsement.