SPYRAL HTN
Global Clinical
Trial program

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Advancing the science of renal denervation

The SPYRAL HTN Global Clinical Trial program, including the SPYRAL HTN-ON MED and SPYRAL HTN-OFF MED trials, is a multi-phase clinical strategy designed to study the renal denervation procedure for patients with uncontrolled hypertension.

CAUTION: Investigational device. Limited by U.S. law to investigational use.

Study design summaries

SPYRAL HTN-OFF MED PIVOTAL Trial

  • Official title: 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 Trial)
  • Population: Up to 331

Go to HTN-OFF MED Pivotal

SPYRAL HTN-ON MED Randomized Clinical Trial

  • Official title: 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)
  • Population: Up to 340

Go to HTN-ON MED IDE

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CAUTION.  Investigational device. Limited by U.S. law to investigational use.