SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study
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“SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study”
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.
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Device - Symplicity Spyralâ„¢ 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.
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.
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Global Clinical Study of Renal Denervation With the Symplicity Spyralâ„¢ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications (SPYRAL PIVOTAL - SPYRAL HTN-OFF MED)
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NCT02439749
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Qe1V0a
