Clinical trial NCT01831895: Controlling and Lowering Blood Pressure With The MOBIUSHD™
Official title: CALM-FIM_US -Controlling and Lowering Blood Pressure With the MobiusHD™ - A Prospective Multicenter Safety Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Carotid Sinus
Lead sponsor: Vascular Dynamics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-15
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.

Detailed description: This is an open-label, multicenter, first-in-man clinical trial to be conducted inside the United States. Eligible subjects with stage 2 resistant systemic arterial hypertension currently being treated with a minimum of three (3) anti-hypertensive drugs, who consent to study participation will be assigned to treatment with the MobiusHD system.

Potential study participants will be consented and then screened at two (2) baseline visits beginning at least 30 days prior to MobiusHD placement. Qualified patients will undergo placement of the MobiusHD under angiographic visualization, and will then be followed for 36 months.

Eligibility criteria: Inclusion Criteria:

* Office cuff SBP ≥ 160 mmHg measured per protocol instructions (Appendix IV) following at least one (1) month of maximally tolerated therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic. Any combination medications will be counted per the active ingredient. (For example, Zestoretic (Lisinopril +HCTZ) equals two (2) anti-hypertensive medications)

Exclusion Criteria:

* Known or clinically suspected baroreflex failure or autonomic neuropathy

Primary outcomes:
measure: Adverse Events
timeFrame: 3 years
Secondary outcomes:
measure: Change in Systolic Office Blood Pressure (OBP)
timeFrame: 3 years
measure: Change in Systolic Ambulatory Blood Pressure (ABPM)
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiology, P.C.
state: Alabama
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Cincinnati
country: United States
facility: The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital
state: Ohio
city: Knoxville
country: United States
facility: Turkey Creek Medical Center
state: Tennessee
Study officials:
affiliation: West Virginia University
name: Mark C Bates, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Kleef MEAM, Devireddy CM, van der Heyden J, Bates MC, Bakris GL, Stone GW, Williams B, Spiering W; CALM-FIM Investigators. Treatment of Resistant Hypertension With Endovascular Baroreflex Amplification: 3-Year Results From the CALM-FIM Study. JACC Cardiovasc Interv. 2022 Feb 14;15(3):321-332. doi: 10.1016/j.jcin.2021.12.015.