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 | 
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.
			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.
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
	
								Cincinnati, Ohio 45219			
	
			
					Principal Investigator: John J Szawaluk, MD, FACC, FAHA, FSCTT
			
						
										Phone: 513-585-1777
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									201 Dowman Dr
Atlanta, Georgia 30303
	
			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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									60 Crittenden Blvd # 70
Rochester, New York 14642
	
			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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								Birmingham, Alabama 35211			
	
			
					Principal Investigator: Farrell Mendelsohn, M.D.
			
						
										Phone: 205-780-4330
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								Des Moines, Iowa 50314			
	
			
					Principal Investigator: Magdhi Ghali, MD
			
						
										Phone: 515-633-3845
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								Knoxville, Tennessee 37934			
	
			
					Principal Investigator: Malcolm Foster, MD
			
						
										Phone: 865-218-7535
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								New Orleans, Louisiana 70121			
	
			
					Principal Investigator: John P Reilly, MD, FACC
			
						
										Phone: 504-842-6832
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								Ypsilanti, Michigan 48197			
	
			
					Principal Investigator: Herbert Aronow, M.D., MPH
			
						
										Phone: 734-712-8387
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