Purpose

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

Conditions

Eligibility

Eligible Ages
Between 20 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg when receiving a medication regimen of one, two, or three antihypertensive medication classes.
  • Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and < 170 mmHg.

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Renal Denervation
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
  • Device: Symplicity Spyral™ multi-electrode renal denervation system
    After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
    Other names:
    • Renal angiography
    • Renal Denervation
Sham Comparator
Sham Procedure
Renal angiography
  • Procedure: Sham Procedure
    After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
    Other names:
    • Renal angiography

Recruiting Locations

Washington DC VA Medical Center
Washington, District of Columbia 20422
Contact:
Vasilios Papademetriou, MD
202-745-8334
Vasilios.Papademetriou@va.gov

More Details

NCT ID
NCT02439775
Status
Recruiting
Sponsor
Medtronic Vascular

Study Contact

K Wandrey
rs.SpyralHTNClinical@medtronic.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.