SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN
Running, not enrolling · Not applicable
Conditions studied: Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT05198674
- Run by
- Medtronic Vascular
- People needed
- 1899
- Starts
- 2021-10-20
- Expected to finish
- 2029-11-30
- Last updated by the study team
- 2026-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
- Individual has a baseline office diastolic blood pressure ≥ 90 mmHg
- Individual has an average systolic baseline home blood pressure ≥135 mmHg
You may not qualify if…
- Individual lacks appropriate renal artery anatomy
- Individual has undergone prior renal denervation
- Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
- Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
- Individual has an estimated glomerular filtration rate (eGFR) of <45
- Individual has one or more episode(s) of orthostatic hypotension
- Individual is pregnant, nursing or planning to become pregnant
- Individual has primary pulmonary hypertension
- Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%
Where it is running
- Banner Heart Hospital — Mesa, Arizona, United States
- Abrazo Arizona Heart Hospital/Biltmore Cardiology — Phoenix, Arizona, United States
- HonorHealth Research Institute — Scottsdale, Arizona, United States
- Arkansas Cardiology — Little Rock, Arkansas, United States
- Scripps Memorial Hospital — La Jolla, California, United States
- University of California, San Francisco — San Francisco, California, United States
- Stanford Hospital and Clinics — Stanford, California, United States
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
- Colorado Heart and Vascular PC — Lakewood, Colorado, United States
- Hartford Hospital — Hartford, Connecticut, United States
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
- BayCare Health System — Clearwater, Florida, United States
- Clearwater Cardiovascular Consultants — Clearwater, Florida, United States
- Baptist Medical Center — Jacksonville, Florida, United States
- University of Miami Hosptial — Miami, Florida, United States
- AdventHealth Orlando — Orlando, Florida, United States
- Orlando Health Heart & Vascular Institute — Orlando, Florida, United States
- BayCare Medical Group — Safety Harbor, Florida, United States
- Tallahassee Memorial Healthcare, Inc — Tallahassee, Florida, United States
- Emory University Hospital Midtown — Atlanta, Georgia, United States
- Piedmont Heart Institute — Atlanta, Georgia, United States
- Wellstar Research Institute — Marietta, Georgia, United States
- University of Chicago Medicine — Chicago, Illinois, United States
- Loyola University Medical Center — Maywood, Illinois, United States
- University of Alabama at Birmingham (UAB) Hospital — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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