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 participate
Inclusion Criteria:
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
Exclusion Criteria:
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%
Interventions
Renal Denervation (Symplicity Spyral™)
DEVICE
Locations
100
Australia (2)
The Alfred Hospital
Melbourne , Victoria
Royal Perth Hospital (Dobney Hypertension Centre)
Perth , Western Australia
Belgium (5)
Algemeen Stedelijk Ziekenhuis - R&D Hartziekten
Aalst , Oost - Vlaanderen
AZ Sint Jan Brugge-Oostende av
Bruges
Ziekenhuis Oost Limburg - Campus Sint-Jan
Genk
University Hospital Ghent
Ghent
Chc Montlegia
Liège
France (2)
Hôpital Saint André -Centre Hospitalier Universitaire de Bordeaux
Bordeaux
Hôpital Pitié Salpêtrière
Paris
Germany (5)
Uniklinik Erlangen
Erlangen
Justus-Liebig-Universität Gießen
Giessen
Universitatsklinikum des Saarlandes
Homburg
Herzzentrum Leipzig
Leipzig
Sana Kliniken Lübeck GmbH
Lübeck
Greece (1)
Hippokration General Hospital of Athens
Athens
Ireland (1)
Mater Misericordiae University Hospital
Dublin , Dublin
Monaco (1)
Centre Hospitalier Princesse Grace
Monaco
Netherlands (2)
Zuyderland Medisch Centrum Heerlen
Heerlen
Erasmus Universtiy Medical Center
Rotterdam
Sweden (1)
Danderyd Sjukhus
Stockholm
United Kingdom (1)
John Radcliffe Hospital
Oxford , Oxfordshire
United States (79)
AnMed Health Medical Center
Anderson , South Carolina
University of Michigan
Ann Arbor , Michigan
Emory University Hospital Midtown
Atlanta , Georgia
Piedmont Heart Institute
Atlanta , Georgia
University of Colorado Anschutz Medical Campus
Aurora , Colorado
The Johns Hopkins Hospital
Baltimore , Maryland
University of Alabama at Birmingham (UAB) Hospital
Birmingham , Alabama
Beth Israel Deaconess Medical Center
Boston , Massachusetts
University of Vermont Medical Center
Burlington , Vermont
University of North Carolina
Chapel Hill , North Carolina
UVA Medical Center
Charlottesville , Virginia
University of Chicago Medicine
Chicago , Illinois
The Lindner Center
Cincinnati , Ohio
BayCare Health System
Clearwater , Florida
Clearwater Cardiovascular Consultants
Clearwater , Florida
University Hospitals Cleveland Medical Center
Cleveland , Ohio
Cleveland Cl inic
Cleveland , Ohio
Riverside Methodist Hospital
Columbus , Ohio
Metropolitan Heart and Vascular Institute (MHVI)
Coon Rapids , Minnesota
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas , Texas
Henry Ford Hospital
Detroit , Michigan
Henry Ford Saint John Hospital
Detroit , Michigan
Duke University Medical Center
Durham , North Carolina
DHR Health Institute for Research and Development
Edinburg , Texas
Providence Regional Medical Center Everett
Everett , Washington
Sanford Medical Center
Fargo , North Dakota
Spectrum Health Hospitals
Grand Rapids , Michigan
UPMC Harrisburg Hospital
Harrisburg , Pennsylvania
Hartford Hospital
Hartford , Connecticut
Houston Methodist
Houston , Texas
St. Vincents Hospital
Indianapolis , Indiana
Baptist Medical Center
Jacksonville , Florida
Scripps Memorial Hospital
La Jolla , California
Colorado Heart and Vascular PC
Lakewood , Colorado
University Medical Center of Southern Nevada
Las Vegas , Nevada
Dartmouth-Hitchcock
Lebanon , New Hampshire
Arkansas Cardiology
Little Rock , Arkansas
SJH Cardiology Associates
Liverpool , New York
North Shore University Hospital
Manhasset , New York
Wellstar Research Institute
Marietta , Georgia
Virtua Medical Group
Marlton , New Jersey
Loyola University Medical Center
Maywood , Illinois
Banner Heart Hospital
Mesa , Arizona
University of Miami Hosptial
Miami , Florida
Advocate Aurora Health-Aurora St. Luke's Medical Center (ASLMC)
Milwaukee , Wisconsin
West Virginia University
Morgantown , West Virginia
Morristown Medical Center
Morristown , New Jersey
Intermountain Medical Center
Murray , Utah
Centennial Medical Center
Nashville , Tennessee
Vanderbilt University Medical Center
Nashville , Tennessee
Jersey Shore University Medical Center
Neptune City , New Jersey
Weill Cornell Medical Center
New York , New York
Oklahoma Heart Hospital
Oklahoma City , Oklahoma
University of Nebraska Medical Center
Omaha , Nebraska
AdventHealth Orlando
Orlando , Florida
Orlando Health Heart & Vascular Institute
Orlando , Florida
Heart Care Centers of Illinois
Palos Park , Illinois
The Valley Hospital
Paramus , New Jersey
Hospital of the University of Pennsylvania
Philadelphia , Pennsylvania
Abrazo Arizona Heart Hospital/Biltmore Cardiology
Phoenix , Arizona
Allegheny General Hospital
Pittsburgh , Pennsylvania
Baylor Scott & White The Heart Hospital Baylor Plano
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