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

Vascular Dynamics

Status: Active, not recruiting

Conditions: Hypertension; Resistant Hypertension

Treatments: Other: Sham Implantation; Device: MobiusHD

Study type: Interventional

Funder types: Industry

Identifiers

NCT03179800

CRD0447

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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300 participants in 2 patient groups

MobiusHD Implantation

Experimental group

Description:

MobiusHD Implantation

Treatment:

Device: MobiusHD

Sham Implantation

Sham Comparator group

Description:

Sham Implantation

Treatment:

Other: Sham Implantation