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

Use our guide to learn which trials are right for you!

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.


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
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...
?
mi
from
Pontiac, MI
Click here to add this to my saved trials
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...
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
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...
?
mi
from
New York, NY
Click here to add this to my saved trials
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...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Anderson, South Carolina 29621
Principal Investigator: Brent McLaurin, MD
Phone: 864-512-8551
?
mi
from
Anderson, SC
Click here to add this to my saved trials
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...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30309
Principal Investigator: David Kandzari, MD
Phone: 404-605-2327
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Dallas, Texas 75226
Principal Investigator: James Choi, MD
Phone: 214-820-2273
?
mi
from
Dallas, TX
Click here to add this to my saved trials
2301 Erwin Rd
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...
?
mi
from
Durham, NC
Click here to add this to my saved trials
2808 Old Post Road
Harrisburg, Pennsylvania 17011
Principal Investigator: William Bachinsky, MD
Phone: 717-920-4400
?
mi
from
Harrisburg, PA
Click here to add this to my saved trials
Hattiesburg, Mississippi 39401
Principal Investigator: Bryan Batson, MD
Phone: 601-268-5794
?
mi
from
Hattiesburg, MS
Click here to add this to my saved trials
Huntsville, Alabama 35801
Principal Investigator: Joshua Krasnow, MD
Phone: 256-519-8280
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
Jacksonville, Florida 32207
Principal Investigator: Marc Litt, M.D.
Phone: 904-202-3885
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Lexington, Kentucky
859) 257-9000
Phone: 859-323-5259
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Melbourne, Victoria 3004
Principal Investigator: Anthony Walton, MD
Phone: +61-3-9426-6693
?
mi
from
Melbourne,
Click here to add this to my saved trials
20 York St, N20 York St,
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...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New York, New York 10021
Principal Investigator: Dmitriy Feldman, MD
?
mi
from
New York, NY
Click here to add this to my saved trials
Saint Louis, Missouri 63110
Principal Investigator: Jasvindar Singh, MD
Phone: 314-362-1962
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
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...
?
mi
from
Southfield, MI
Click here to add this to my saved trials
Stanford, California 94305
Principal Investigator: David Lee, MD
Phone: 650-723-2094
?
mi
from
Stanford, CA
Click here to add this to my saved trials
Tupelo, Mississippi 38801
Principal Investigator: Barry Bertolet, MD
Phone: 662-377-7456
?
mi
from
Tupelo, MS
Click here to add this to my saved trials
Washington, District of Columbia 20422
Phone: 202-745-8334
?
mi
from
Washington,
Click here to add this to my saved trials
West Des Moines, Iowa 50266
Principal Investigator: Magdi Ghali, MD
Phone: 515-633-3842
?
mi
from
West Des Moines, IA
Click here to add this to my saved trials