This study is in progress, not accepting new patients

SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN

a study on High Blood Pressure Vascular Disease Cardiovascular Disease Chronic Kidney Disease Kidney Disease Diabetes

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco 5391959, California 5332921 and other locations
Dates
study started
study ends around

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, Chronic Renal Insufficiency, Renal Denervation (Symplicity Spyral™)

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
  2. Individual has a baseline office diastolic blood pressure ≥ 90 mmHg
  3. Individual has an average systolic baseline home blood pressure ≥135 mmHg

You CAN'T join if...

  1. Individual lacks appropriate renal artery anatomy
  2. Individual has undergone prior renal denervation
  3. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
  4. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
  5. Individual has an estimated glomerular filtration rate (eGFR) of <45
  6. Individual has one or more episode(s) of orthostatic hypotension
  7. Individual is pregnant, nursing or planning to become pregnant
  8. Individual has primary pulmonary hypertension
  9. Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%

Locations

  • UCSF
    San Francisco 5391959 California 5332921 94143 United States
  • Stanford Hospital and Clinics
    Stanford 5398563 California 5332921 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medtronic Vascular
ID
NCT05198674
Study Type
Interventional
Participants
Expecting 1400 study participants
Last Updated