CALM- 2 - 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: | 3/2/2019 | 
| Start Date: | October 19, 2017 | 
| End Date: | May 2026 | 
| Contact: | Tamara Shipman, BSN | 
| Email: | tshipman@vasculardynamics.com | 
| Phone: | 650-208-1118 | 
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.
			System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal
study.
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.
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.
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.
We found this trial at
    17
    sites
	
								Cincinnati, Ohio 45219			
	
			
					Principal Investigator: John J Szawaluk, MD, FACC, FAHA, FSCTT
			
						
										Phone: 513-585-1777
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									1720 2nd Ave S
Birmingham, Alabama 35233
	
			Birmingham, Alabama 35233
(205) 934-4011  
							 
					Principal Investigator: Suzanne Oparil, MD, FACC, FAHA, FASH, FAPS
			
						
										Phone: 205-934-7279
					
		University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...  
  
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									5801 South Ellis Avenue
Chicago, Illinois 60637
	
			Chicago, Illinois 60637
 773.702.1234 
							 
					Principal Investigator: Sandeep Nathan, MD
			
						
										Phone: 347-506-8518
					
		University of Chicago One of the world's premier academic and research institutions, the University of...  
  
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								Los Angeles, California 90033			
	
			213) 740-2311 
							 
					Principal Investigator: Mitra Nadim, MD
			
						
										Phone: 323-442-5693
					
		University of Southern California The University of Southern California is one of the world’s leading...  
  
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									550 Peachtree St NE
Atlanta, Georgia 30308
	
			Atlanta, Georgia 30308
(404) 686-4411
							 
					Principal Investigator: Janice Lea, MD, MSc, FASN
			
						
										Phone: 404-686-3872
					
		Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...  
  
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								Beaumont, Texas 77702			
	
			
					Principal Investigator: Paris P Bransford, MD
			
						
										Phone: 409-839-4003
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								Lambeth, London 			
	
			
					Principal Investigator: Philip J Chowienczyk
			
						
										Phone: +44 (0) 207 188 4768
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								Lexington, Kentucky 40536			
	
			
					Principal Investigator: John R Kotter, MD
			
						
										Phone: 859-323-1082
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								New Haven, Connecticut 6520			
	
			(203) 432-4771 
							 
					Principal Investigator: Aldo Peixoto, MD
			
						
										Phone: 203-737-8010
					
		Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...  
  
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									1514 Jefferson Hwy.
New Orleans, Louisiana 70121
	
			New Orleans, Louisiana 70121
504-842-3000
							 
					Principal Investigator: Michael E Cash, MD
			
						
										Phone: 504-842-8093
					
		Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...  
  
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								Philadelphia, Pennsylvania 19141			
	
			
					Principal Investigator: Vincent M Figueredo, MD, FAHA, FACC
			
						
										Phone: 215-456-6736
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								Reno, Nevada 89502			
	
			
					Principal Investigator: Michael J Bloch, MD, FACP, FASH, FSVM, FNLA
			
						
										Phone: 775-982-2045
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									18001 East 10 Mile Road
Roseville, Michigan 48066
	
			
					Roseville, Michigan 48066
Principal Investigator: Christopher R Provenzano, MD
			
						
										Phone: 313-432-6254
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									5300 Tallman Ave NW
Seattle, Washington 98122
	
			Seattle, Washington 98122
(206) 782-2700
							 
					Principal Investigator: Vijay Vidyasagar, MD
			
						
										Phone: 206-386-6462
					
		Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...  
  
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									327 W Calhoun Ave
Springfield, Illinois 62702
	
			Springfield, Illinois 62702
(217) 545-0223
							 
					Principal Investigator: John M Flack, MD, MPH, FAHA, FASH
			
						
										Phone: 217-545-4402
					
		Southern Illinois University From its humble beginnings as the state's second teachers college - founded...  
  
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								Tampa, Florida 33614			
	
			
					Principal Investigator: Jesus O Nvarro, MD
			
						
										Phone: 813-873-1016
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								West Des Moines, Iowa 50266			
	
			
					Principal Investigator: Randolph R Rough, MD
			
						
										Phone: 515-633-3845
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