Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)



Status:Active, not recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:September 2011

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The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized,
controlled study of the safety and effectiveness of renal denervation in subjects with
uncontrolled hypertension. Bilateral renal denervation will be performed using the
Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF)energy through
the luminal surface of the renal artery.


Inclusion Criteria:

- Individual is ≥ 18 and ≤ 80 years old at time of randomization.

- Individual is receiving a stable medication regimen including full tolerated doses of
3 or more anti-hypertensive medications of different classes, of which one must be a
diuretic (with no changes for a minimum of 2 weeks prior to screening) that is
expected to be maintained without changes for at least 6 months.

- Individual has an office systolic blood pressure (SBP) of ≥ 160 mmHg based on an
average of 3 blood pressure readings measured at both an initial screening visit and
a confirmatory screening visit

Exclusion Criteria:

- Individual has an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2

- Individual has an Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP <
135 mmHg

- Individual has type 1 diabetes mellitus

- Individual requires chronic oxygen support or mechanical ventilation (e.g.,
tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.

- Individual has primary pulmonary hypertension.

- Individual is pregnant, nursing or planning to be pregnant.
We found this trial at
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Springfield, Illinois 62701
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621 West Lombard Street
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75 Francis street
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450 Clarkson Avenue
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5801 South Ellis Avenue
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4201 Belfort Road
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8700 Beverly Blvd # 8211
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Miami, Florida 33124
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1 Tampa General Cir
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500 S State St
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Atlanta, Georgia 30309
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550 Peachtree St NE
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12605 East 16th Avenue
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Browns Mills, New Jersey 08015
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111 Colchester Ave
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Chapel Hill, North Carolina 27599
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171 Ashley Avenue
Charleston, South Carolina 29425
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Charlotte, North Carolina 28203
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Charlottesville, Virginia 22903
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303 East Superior Street
Chicago, Illinois 60611
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100 North Academy Avenue
Danville, Pennsylvania 17822
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555 N Duke St
Lancaster, Pennsylvania 17602
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4733 Sunset Blvd
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
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1514 Jefferson Hwy.
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630 W 168th St
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