Clinical trial NCT03179800: CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™
Official title: CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Resistant Hypertension
Keywords: Hypertension
Resistant Hypertension
Baroreceptor
BAT
Lead sponsor: Vascular Dynamics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Primary Effectiveness Endpoint - Change in mean 24-hr sABP from baseline to 180-day
timeFrame: 180-day
Secondary outcomes:
Other outcomes:
measure: Safety Assessments - Composite measured at 90-day
timeFrame: 90-day
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Springfield
country: United States
facility: Southern Illinois University
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indiana
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Cincinnati
country: United States
facility: The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital
state: Ohio
city: Nancy
country: France
facility: CHU Nancy Centre Coeur et Vaisseaux
Study officials:
affiliation: University College, London
name: Bryan Williams, MD
role: STUDY_CHAIR
affiliation: Cardiovascular Research and Education Columbia University Medical Center
name: Gregg Stone, MD
role: STUDY_CHAIR
References:
citation: Calhoun DA, Schiffrin EL, Flack JM. Resistant Hypertension: An Update. Am J Hypertens. 2019 Jan 1;32(1):1-3. doi: 10.1093/ajh/hpy156. No abstract available.