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SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System
SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System

NCT02439775

CompletedNA

Sponsor: Medtronic Vascular

Conditions: Hypertension, Vascular Diseases, Cardiovascular Diseases

Interventions: Symplicity Spyral™ multi-electrode renal denervation system, Sham Procedure

Countries: United States, Australia, Austria, Canada, France, Germany, Greece, Ireland

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.

Eligibility overview

Sex: ALL

Age: 20 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (56)
  • Huntsville, Alabama, United States
  • Stanford, California, United States
  • New Haven, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Jacksonville, Florida, United States
  • Jacksonville, Florida, United States
  • Tallahassee, Florida, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • West Des Moines, Iowa, United States
  • Lexington, Kentucky, United States
  • Pontiac, Michigan, United States
  • Southfield, Michigan, United States
  • Minneapolis, Minnesota, United States
  • Hattiesburg, Mississippi, United States
  • Tupelo, Mississippi, United States
  • St Louis, Missouri, United States
  • Livingston, New Jersey, United States
  • Manhasset, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Durham, North Carolina, United States
  • Cleveland, Ohio, United States
  • Portland, Oregon, United States
  • Harrisburg, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Providence, Rhode Island, United States
  • Anderson, South Carolina, United States
  • Nashville, Tennessee, United States
  • Dallas, Texas, United States
  • + 26 more on CT.gov