CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Vascular Dynamics, Inc.
- Enrollment
- 300
- Locations
- 6
- Primary Endpoint
- Primary Effectiveness Endpoint - Change in mean 24-hr sABP from baseline to 180-day
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Primary Effectiveness Endpoint - Change in mean 24-hr sABP from baseline to 180-day
Time Frame: 180-day
The primary effectiveness endpoint is change in mean 24-hr ambulatory systolic blood pressure (24hr sABP) from baseline to the 180-day visit.