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

Completed · Not applicable · Has a placebo group

Conditions studied: Hypertension, Vascular Diseases, Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT02439775

Run by

Medtronic Vascular

People needed

337

Starts

2015-07-22

Expected to finish

2025-08-14

Last updated by the study team

2026-07-30

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford Hospital and Clinics — Stanford, California, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Washington DC VA Medical Center — Washington D.C., District of Columbia, United States
• Baptist Medical Center Jacksonville — Jacksonville, Florida, United States
• Memorial Hospital Jacksonville — Jacksonville, Florida, United States
• Tallahassee Research Institute — Tallahassee, Florida, United States
• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Iowa Heart Center — West Des Moines, Iowa, United States
• University of Kentucky — Lexington, Kentucky, United States
• St Joseph Mercy Oakland — Pontiac, Michigan, United States
• Providence Hospital — Southfield, Michigan, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• Hattiesburg Clinic — Hattiesburg, Mississippi, United States
• Cardiology Associates Research LLC — Tupelo, Mississippi, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Saint Barnabas Medical Center — Livingston, New Jersey, United States
• North Shore University Hospital — Manhasset, New York, United States
• Weill Cornell Medical College/The New York Presbyterian Hospital — New York, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Oregon Health & Science University Hospital — Portland, Oregon, United States
• PinnacleHealth Cardiovascular Institute — Harrisburg, Pennsylvania, United States
• Heart Center Research, LLC — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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