Clinical Trial

SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study

Study Description

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Recruiting patients only Recruiting patients only

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.

Additional Information

Official Study Title

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)

Clinical Trial ID

NCT02439749

ParticipAid ID

Qe1V0a