Trial Search Results
SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension
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.
Stanford is currently not accepting patients for this trial.
- Device: Renal denervation (Symplicity Catheter System)
- Diagnostic Test: Renal angiogram
- 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
- 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 <
- 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.
Ages Eligible for Study
18 Years - 80 Years
Genders Eligible for Study