SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN (NCT05198674)
The SPYRAL AFFIRM Global Clinical Study of Renal Denervation With the Symplicity Spyral Renal Denervation System in Subjects With Uncontrolled Hypertension (SPYRAL AFFIRM)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (10 items).
Location: University of Alabama at Birmingham (UAB) Hospital — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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%
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (99 Sites)
Showing the first 25 of 99 sites.
- University of Alabama at Birmingham (UAB) Hospital — Birmingham, Alabama
- Banner Heart Hospital — Mesa, Arizona
- Abrazo Arizona Heart Hospital/Biltmore Cardiology — Phoenix, Arizona
- HonorHealth Research Institute — Scottsdale, Arizona
- Arkansas Cardiology — Little Rock, Arkansas
- Scripps Memorial Hospital — La Jolla, California
- University of California, San Francisco — San Francisco, California
- Stanford Hospital and Clinics — Stanford, California
- University of Colorado Anschutz Medical Campus — Aurora, Colorado
- Colorado Heart and Vascular PC — Lakewood, Colorado
- Hartford Hospital — Hartford, Connecticut
- MedStar Washington Hospital Center — Washington D.C., District of Columbia
- BayCare Health System — Clearwater, Florida
- Clearwater Cardiovascular Consultants — Clearwater, Florida
- Baptist Medical Center — Jacksonville, Florida
- University of Miami Hosptial — Miami, Florida
- AdventHealth Orlando — Orlando, Florida
- Orlando Health Heart & Vascular Institute — Orlando, Florida
- BayCare Medical Group — Safety Harbor, Florida
- Tallahassee Memorial Healthcare, Inc — Tallahassee, Florida
- Emory University Hospital Midtown — Atlanta, Georgia
- Piedmont Heart Institute — Atlanta, Georgia
- Wellstar Research Institute — Marietta, Georgia
- University of Chicago Medicine — Chicago, Illinois
- Loyola University Medical Center — Maywood, Illinois
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.