SPYRAL HTN-ON MED Study
| Status: | Recruiting | 
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Peripheral Vascular Disease, Cardiology | 
| Therapuetic Areas: | Cardiology / Vascular Diseases | 
| Healthy: | No | 
| Age Range: | 20 - 80 | 
| Updated: | 3/30/2019 | 
| Start Date: | July 2015 | 
| End Date: | February 2024 | 
| Contact: | K Wandrey | 
| Email: | rs.SpyralHTNClinical@medtronic.com | 
Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension on Standard Medical Therapy (SPYRAL HTN-ON MED)
The purpose of this study is to test the hypothesis that renal denervation decreases blood
pressure and is safe when studied in the presence of up to three standard antihypertensive
medications.
			pressure and is safe when studied in the presence of up to three standard antihypertensive
medications.
Inclusion Criteria:
- Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg and a
diastolic blood pressure (DBP) ≥ 90 mmHg when receiving a medication regimen of one,
two, or three antihypertensive medication classes.
- Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140
mmHg and < 170 mmHg.
Exclusion Criteria:
- Individual lacks appropriate renal artery anatomy.
- Individual has estimated glomerular filtration rate (eGFR) of <45.
- Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.
- Individual has one or more episodes of orthostatic hypotension.
- Individual requires chronic oxygen support or mechanical ventilation other than
nocturnal respiratory support for sleep apnea.
- Individual has primary pulmonary hypertension.
- Individual is pregnant, nursing or planning to become pregnant.
- Individual has frequent intermittent or chronic pain that results in treatment with
nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the
month prior to enrollment
- Individual has experienced a myocardial infarction, unstable angina pectoris, syncope,
or a cerebrovascular accident within three months of the screening period, or has
widespread atherosclerosis, with documented intravascular thrombosis or unstable
plaques.
- Individual works night shifts.
We found this trial at
    23
    sites
	
								Jacksonville, Florida 32207			
	
			
					Principal Investigator: Marc Litt, M.D.
			
						
										Phone: 904-202-3885
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									300 Community Drive
Manhasset, New York 11030
	
			Manhasset, New York 11030
(516) 562-0100
							
					Principal Investigator: Avneet Singh, MD
			
						
										Phone: 516-562-4100
					
		North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...  
  
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									1 Gustave L Levy Pl # 271
New York, New York 10029
	
			New York, New York 10029
 (212) 241-6500 
							
					Principal Investigator: George D. Dangas, MD
			
						
										Phone: 212-241-8228
					
		Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...  
  
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									3400 Spruce St
Philadelphia, Pennsylvania 19104
	
			Philadelphia, Pennsylvania 19104
 (215) 662-4000 
							
					Principal Investigator: Debbie Cohen, MD
			
						
										Phone: 215-615-0773
					
		Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...  
  
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								Anderson, South Carolina 29621			
	
			
					Principal Investigator: Brent McLaurin, MD
			
						
										Phone: 864-512-8551
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									550 Peachtree St NE
Atlanta, Georgia 30308
	
			Atlanta, Georgia 30308
(404) 686-4411
							
					Principal Investigator: Chandan Devireddy, MD
			
						
										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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								Atlanta, Georgia 30309			
	
			
					Principal Investigator: David Kandzari, MD
			
						
										Phone: 404-605-2327
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								Dallas, Texas 75226			
	
			
					Principal Investigator: James Choi, MD
			
						
										Phone: 214-820-2273
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									2301 Erwin Rd
Durham, North Carolina 27710
	
			Durham, North Carolina 27710
919-684-8111
							
					Principal Investigator: Manesh Patel, MD
			
						
										Phone: 919-681-4959
					
		Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...  
  
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									2808 Old Post Road
Harrisburg, Pennsylvania 17011
	
			
					Harrisburg, Pennsylvania 17011
Principal Investigator: William Bachinsky, MD
			
						
										Phone: 717-920-4400
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								Hattiesburg, Mississippi 39401			
	
			
					Principal Investigator: Bryan Batson, MD
			
						
										Phone: 601-268-5794
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								Huntsville, Alabama 35801			
	
			
					Principal Investigator: Joshua Krasnow, MD
			
						
										Phone: 256-519-8280
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		University of Kentucky The University of Kentucky is a public, land grant university dedicated to...  
  
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								Melbourne, Victoria 3004			
	
			
					Principal Investigator: Anthony Walton, MD
			
						
										Phone: +61-3-9426-6693
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									20 York St, N20 York St,
New Haven, Connecticut 06520
	
			New Haven, Connecticut 06520
(203) 688-4242
							
					Principal Investigator: Michael Remetz, MD
			
						
										Phone: 207-737-8871
					
		Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...  
  
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								New York, New York 10021			
	
			
					Principal Investigator: Dmitriy Feldman, MD
			
						
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									44405 Woodward Ave
Pontiac, Michigan 48341
	
			Pontiac, Michigan 48341
(248) 858-3000
							
					Principal Investigator: Kirit Patel, MD
			
						
										Phone: 248-858-6962
					
		St. Joseph Mercy Oakland St. Joseph Mercy Oakland (SJMO) is a 443-bed comprehensive, community and...  
  
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								Saint Louis, Missouri 63110			
	
			
					Principal Investigator: Jasvindar Singh, MD
			
						
										Phone: 314-362-1962
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									16001 W 9 Mile Rd
Southfield, Michigan 48075
	
			Southfield, Michigan 48075
(248) 849-3000
							
					Principal Investigator: Shukri David, MD
			
						
										Phone: 248-849-3369
					
		Providence Hospital St. John Providence Health System is comprised of five hospitals plus more than...  
  
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								Stanford, California 94305			
	
			
					Principal Investigator: David Lee, MD
			
						
										Phone: 650-723-2094
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								Tupelo, Mississippi 38801			
	
			
					Principal Investigator: Barry Bertolet, MD
			
						
										Phone: 662-377-7456
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								West Des Moines, Iowa 50266			
	
			
					Principal Investigator: Magdi Ghali, MD
			
						
										Phone: 515-633-3842
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