I'm Interested

Trial ID: NCT02439749


The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the absence of antihypertensive medications.

Official Title

Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications (SPYRAL PIVOTAL - SPYRAL HTN-OFF MED)

Stanford Investigator(s)

Alan Yeung, MD
Alan Yeung, MD

Li Ka Shing Professor in Cardiology

David Lee, MD
David Lee, MD

Professor of Medicine (Cardiovascular Medicine)


Inclusion Criteria:

   - Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg and a
   diastolic blood pressure (DBP) ≥ 90 mmHg after being off medications.

   - Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140
   mmHg and < 170 mmHg.

   - Individual is willing to discontinue current antihypertensive medications.

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 stable or unstable angina within 3 months of enrollment, myocardial
   infarction within 3 months of enrollment; heart failure, cerebrovascular accident or
   transient ischemic attack, or atrial fibrillation at any time.

   - Individual works night shifts.


device: Symplicity Spyral™ multi-electrode renal denervation system

procedure: Sham Procedure


I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maria E Perlas