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CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™
Recruiting
Trial ID: NCT03179800
Purpose
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.
Official Title
CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™
Stanford Investigator(s)
Tara I. Chang
Stanford University Professor of Nephrology
Eligibility
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.
Intervention(s):
device: MobiusHD
other: Sham Implantation
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305