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SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study
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.
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)
- 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.
- 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