Status:
COMPLETED
Controlling and Lowering Blood Pressure With The MOBIUS HD™ (CALM-FIM_EUR)
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 in Europe. Eligible subjects with stage 2 resistant systemic arterial hypertension currently being treated with a minimu...
Eligibility Criteria
Inclusion
- Office cuff SBP ≥ 160 mmHg measured per protocol instructions 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 unless patient has history of intolerance, ineffectiveness or contraindications.
Exclusion
- Known or clinically suspected baroreflex failure or autonomic neuropathy
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01911897
Start Date
June 1 2013
End Date
February 28 2020
Last Update
November 22 2023
Active Locations (6)
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1
University of Cologne
Cologne, Germany, 50937
2
Maastricht University Medical Center
Maastricht, AZ, Netherlands, 6202
3
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3430 EM
4
Erasmus Medical Center
Rotterdam, Netherlands, 3015