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

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.