Controlling and Lowering Blood Pressure With The MOBIUSHD™



Status:Recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:11/30/2016
Start Date:May 2013
End Date:June 2020
Contact:Sujith J Shetty, MBBS
Email:sshetty@vasculardynamics.com
Phone:650-963-9370

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CALM-FIM_US -Controlling and Lowering Blood Pressure With the MobiusHD™ - A Prospective Multicenter Safety Study

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

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.

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
We found this trial at
8
sites
Knoxville, Tennessee 37934
Principal Investigator: Malcolm Foster, MD
Phone: 865-218-7535
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Chandan Devireddy, MD
Phone: 404-686-3872
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Craig Narins, M.D.
Phone: 585-341-7764
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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Birmingham, Alabama 35211
Principal Investigator: Farrell Mendelsohn, M.D.
Phone: 205-780-4330
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Birmingham, AL
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Cincinnati, Ohio 45219
Principal Investigator: John J Szawaluk, MD, FACC, FAHA, FSCTT
Phone: 513-585-1777
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Cincinnati, OH
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Des Moines, Iowa 50314
Principal Investigator: Magdhi Ghali, MD
Phone: 515-633-3845
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Des Moines, IA
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New Orleans, Louisiana 70121
Principal Investigator: John P Reilly, MD, FACC
Phone: 504-842-6832
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New Orleans, LA
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Ypsilanti, Michigan 48197
Principal Investigator: Herbert Aronow, M.D., MPH
Phone: 734-712-8387
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Ypsilanti, MI
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