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.

Lead Sponsor:

Medtronic Vascular

Stanford Investigator(s):

Intervention(s):

  • Device: Renal denervation (Symplicity Catheter System)
  • Diagnostic Test: Renal angiogram

Phase:

N/A

Eligibility


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.

Ages Eligible for Study

18 Years - 80 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maria Perlas
650-723-2094
Not Recruiting