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SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN
Sponsor: Medtronic Vascular
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1300
Start Date
2021-10-20
Completion Date
2029-11-30
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
Renal Denervation (Symplicity Spyral™)
Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.
Locations (100)
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, United States
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
Heart Care Centers of Illinois
Palos Park, Illinois, United States
St. Vincents Hospital
Indianapolis, Indiana, United States
Mercy Medical Center
West Des Moines, Iowa, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Saint Joseph Medical Center (Towson MD)
Towson, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Henry Ford Saint John Hospital
Detroit, Michigan, United States
Spectrum Health Hospitals
Grand Rapids, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Henry Ford Providence Southfield Hospital
Southfield, Michigan, United States
Metropolitan Heart and Vascular Institute (MHVI)
Coon Rapids, Minnesota, United States
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Dartmouth-Hitchcock
Lebanon, New Hampshire, United States
Virtua Medical Group
Marlton, New Jersey, United States
Morristown Medical Center
Morristown, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
The Valley Hospital
Paramus, New Jersey, United States
SJH Cardiology Associates
Liverpool, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Weill Cornell Medical Center
New York, New York, United States
Saint Francis Hospital
Roslyn, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Sanford Medical Center
Fargo, North Dakota, United States
The Lindner Center
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Cl inic
Cleveland, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
UPMC Harrisburg Hospital
Harrisburg, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital and Health Services
Providence, Rhode Island, United States
AnMed Health Medical Center
Anderson, South Carolina, United States
Centennial Medical Center
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, United States
DHR Health Institute for Research and Development
Edinburg, Texas, United States
Houston Methodist
Houston, Texas, United States
Baylor Scott & White The Heart Hospital Baylor Plano
Plano, Texas, United States
Methodist Hospital
San Antonio, Texas, United States
The University of Texas at Tyler
Tyler, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Vermont Medical Center
Burlington, Vermont, United States
UVA Medical Center
Charlottesville, Virginia, United States
Providence Regional Medical Center Everett
Everett, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
Advocate Aurora Health-Aurora St. Luke's Medical Center (ASLMC)
Milwaukee, Wisconsin, United States
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Perth Hospital (Dobney Hypertension Centre)
Perth, Western Australia, Australia
Algemeen Stedelijk Ziekenhuis - R&D Hartziekten
Aalst, Oost - Vlaanderen, Belgium
AZ Sint Jan Brugge-Oostende av
Bruges, Belgium
Ziekenhuis Oost Limburg - Campus Sint-Jan
Genk, Belgium
University Hospital Ghent
Ghent, Belgium
Chc Montlegia
Liège, Belgium
Hôpital Saint André -Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France
Hôpital Pitié Salpêtrière
Paris, France
Uniklinik Erlangen
Erlangen, Germany
Justus-Liebig-Universität Gießen
Giessen, Germany
Universitatsklinikum des Saarlandes
Homburg, Germany
Herzzentrum Leipzig
Leipzig, Germany
Sana Kliniken Lübeck GmbH
Lübeck, Germany
Hippokration General Hospital of Athens
Athens, Greece
Mater Misericordiae University Hospital
Dublin, Dublin, Ireland
Centre Hospitalier Princesse Grace
Monaco, Monaco
Zuyderland Medisch Centrum Heerlen
Heerlen, Netherlands
Erasmus Universtiy Medical Center
Rotterdam, Netherlands
Danderyd Sjukhus
Stockholm, Sweden
John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom