Status:
COMPLETED
Controlling and Lowering Blood Pressure With The MOBIUSHD™
Lead Sponsor:
Vascular Dynamics, Inc.
Conditions:
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.
Detailed Description
This is an open-label, multicenter, first-in-man clinical trial to be conducted inside the United States. Eligible subjects with stage 2 resistant systemic arterial hypertension currently being treate...
Eligibility Criteria
Inclusion
- Office cuff SBP ≥ 160 mmHg measured per protocol instructions (Appendix IV) following at least one (1) month of maximally tolerated therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic. Any combination medications will be counted per the active ingredient. (For example, Zestoretic (Lisinopril +HCTZ) equals two (2) anti-hypertensive medications)
Exclusion
- Known or clinically suspected baroreflex failure or autonomic neuropathy
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2021
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01831895
Start Date
May 1 2013
End Date
April 13 2021
Last Update
May 6 2023
Active Locations (7)
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1
Cardiology, P.C.
Birmingham, Alabama, United States, 35211
2
Emory University
Atlanta, Georgia, United States, 30308
3
Iowa Heart Center
Des Moines, Iowa, United States, 50309
4
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121