SPYRAL PIVOTAL - SPYRAL HTN-OFF 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:June 2015
End Date:December 2022
Contact:K Wandrey
Email:rs.SpyralHTNClinical@medtronic.com

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Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications (SPYRAL PIVOTAL - SPYRAL HTN-OFF MED)

The purpose of this study is to test the hypothesis that renal denervation decreases blood
pressure and is safe when studied in the absence of antihypertensive medications.


Inclusion Criteria:

- Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg and a
diastolic blood pressure (DBP) ≥ 90 mmHg after being off medications.

- Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140
mmHg and < 170 mmHg.

- Individual is willing to discontinue current antihypertensive medications.

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
31
sites
16001 W 9 Mile Rd
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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Southfield, MI
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300 Community Drive
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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Manhasset, NY
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1 Gustave L Levy Pl # 271
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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New York, NY
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3400 Spruce St
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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Philadelphia, PA
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Anderson, South Carolina 29621
Principal Investigator: Brent McLaurin, MD
Phone: 864-512-8551
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Anderson, SC
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550 Peachtree St NE
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, GA
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Atlanta, Georgia 30309
Principal Investigator: David Kandzari, MD
Phone: 404-605-4098
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Atlanta, GA
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Charleston, West Virginia 25304
Principal Investigator: Aravinda Nanjundappa, MD
Phone: 304-388-9679
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Charleston, WV
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Cleveland, Ohio 44012
Principal Investigator: Mehdi Shishehbor, DO
Phone: 216-844-3801
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Cleveland, OH
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Dallas, Texas 75226
Principal Investigator: James Choi, MD
Phone: 214-820-2273
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Dallas, TX
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Manesh Patel, MD
Phone: 919-684-9255
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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2808 Old Post Road
Harrisburg, Pennsylvania 17011
Principal Investigator: William Bachinsky, MD
Phone: 717-920-4400
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Harrisburg, PA
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Hattiesburg, Mississippi 39401
Principal Investigator: Bryan Batson, MD
Phone: 601-268-5794
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Hattiesburg, MS
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Huntsville, Alabama 35801
Principal Investigator: Joshua Krasnow, MD
Phone: 256-519-8280
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Huntsville, AL
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Jacksonville, Florida 32207
Principal Investigator: Marc Litt, M.D.
Phone: 904-202-3885
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Jacksonville, FL
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Lexington, KY
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94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
Principal Investigator: Sabino Torre, MD
Phone: 973-926-6987
Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
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Livingston, NJ
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Los Angeles, California 90027
Principal Investigator: Somjot Brar, MD
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Los Angeles, CA
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Melbourne, Victoria 3004
Principal Investigator: Anthony Walton, MD
Phone: +61-3-9426-6693
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Melbourne,
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Principal Investigator: Suhail Allaqaband, MD
Phone: 414-649-3490
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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Milwaukee, WI
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Minneapolis, Minnesota 55407
Principal Investigator: Yale Wang, MD
Phone: 612-863-6051
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Minneapolis, MN
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Nashville, Tennessee 37203
Principal Investigator: Brian Jefferson, MD
Phone: 615-329-7641
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Nashville, TN
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Principal Investigator: Michael Remetz, MD
Phone: 203-737-8871
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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New Haven, CT
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44405 Woodward Ave
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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Pontiac, MI
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164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
Principal Investigator: Herbert Aronow, MD
Phone: 401-793-4107
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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Providence, RI
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Saint Louis, Missouri 63110
Principal Investigator: Jasvindar Singh, MD
Phone: 314-362-1962
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Saint Louis, MO
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10510 North 92nd Street
Scottsdale, Arizona 85251
Principal Investigator: Bimal Padaliya, MD
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Scottsdale, AZ
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Stanford, California 94305
Principal Investigator: David Lee, MD
Phone: 650-723-2094
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Stanford, CA
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Tallahassee, Florida 32308
Principal Investigator: Thomas Noel, MD
Phone: 850-431-5024
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Tupelo, Mississippi 38801
Principal Investigator: Barry Bertolet, MD
Phone: 662-377-7456
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Tupelo, MS
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West Des Moines, Iowa 50266
Principal Investigator: Magdi Ghali, MD
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West Des Moines, IA
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