Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around
Principal Investigator
by Sammy Elmariah, MD, MPH

Description

Summary

The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation.

Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies.

Official Title

The SPYRAL AFFIRM Global Clinical Study of Renal Denervation With the Symplicity Spyral Renal Denervation System in Subjects With Uncontrolled Hypertension (SPYRAL AFFIRM)

Keywords

Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus, Kidney Diseases, Chronic Renal Insufficiency, Renal Denervation (Symplicity Spyral™)

Eligibility

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • Stanford Hospital and Clinics accepting new patients
    Stanford California 94305 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medtronic Vascular
ID
NCT05198674
Study Type
Interventional
Participants
Expecting 1400 study participants
Last Updated