SPYRAL HTN-ON MED RANDOMIZED CLINICAL TRIAL

HTN-ON MED TRIAL DESIGN

Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension on Standard Medical Therapy (SPYRAL HTN-ON MED)

PRIMARY OUTCOME MEASURES

Decorative image

Acute and chronic safety by evaluating incidence of major adverse events from baseline to one month post-procedure or six months for new renal artery stenosis
 

Decorative image

Change in systolic blood pressure as measured by 24-hour ambulatory blood pressure monitoring (ABPM) from baseline to six months post-procedure
 

DESIGN DETAILS

  • Estimated Enrollment: 340 participants
  • Study Type: Interventional (Clinical Trial)
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Treatment
  • Actual Study Start Date: July 2015
SEE THE FULL DESIGN MANUSCRIPT

This trial is currently recruiting. More details are available at SpyralHTNtrials.com

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1

Measurement started after witnessed drug ingestion.

2

Drug testing.