CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™

  • Interventional
  • Recruiting
  • NCT03179800
Eligibility Details Visit Clinicaltrials.gov

CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™

The objective of this study is to evaluate the safety and effectiveness of the MobiusHD System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal study.

The objective of this study is to evaluate the safety and effectiveness of the MobiusHD System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal study. Patients with resistant hypertension who remain uncontrolled despite pharmacologic treatment with maximum tolerated, guideline-directed anti-hypertensive pharmacologic therapy will be evaluated.

Gender
All

Age Group
18 Years to 80 Years

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Mean 24 hour ambulatory systolic blood pressure ≥145 mmHg and ≤200 mmHg and stable for at least 8 weeks on a maximally tolerated guideline directed, (JNC8) or their equivalent when those listed are not available dosing regimen consisting of up to 5 antihypertensive medications, with a minimum required dosing regimen of an "A+C+D" antihypertensive medication regimen, where "A" is an angiotensin-converting enzyme Inhibitor or an angiotensin receptor blocker, "C" is a calcium channel blocker, and "D" is a diuretic.

        Exclusion Criteria:

         - Inadequacy of the carotid anatomy for treatment with the MobiusHD based on carotid angiography.

At a Glance

National Government IDNCT03179800

IRB#IRB17-1430

Lead SponsorVascular Dynamics, Inc.

Lead PhysicianSandeep Nathan

Collaborator(s)N/A

EligibilityAll
18 Years to 80 Years
Recruiting