337
Participants
Start Date
July 31, 2015
Primary Completion Date
August 18, 2022
Study Completion Date
September 28, 2025
Symplicity Spyral™ multi-electrode renal denervation system
After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
Sham Procedure
After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Alfred Hospital, Melbourne
Klinikum Wels-Grieskirchen, Wels
Weill Cornell Medical College/The New York Presbyterian Hospital, New York
Mount Sinai Medical Center, New York
North Shore University Hospital, Manhasset
Hippokration General Hospital of Athens, Athens
PinnacleHealth Cardiovascular Institute, Harrisburg
Hospital of the University of Pennsylvania, Philadelphia
Washington DC VA Medical Center, Washington D.C.
Sana Kliniken Lübeck, Lübeck
Charleston Area Medical Center, Charleston
Duke University Medical Center, Durham
AnMed Health, Anderson
Emory University Hospital Midtown, Atlanta
Piedmont Heart Institute, Atlanta
Baptist Medical Center Jacksonville, Jacksonville
Memorial Hospital Jacksonville, Jacksonville
Tallahassee Research Institute, Tallahassee
Heart Center Research, LLC, Huntsville
Centennial Medical Center, Nashville
Cardiology Associates Research LLC, Tupelo
Hattiesburg Clinic, Hattiesburg
University of Kentucky, Lexington
University Hospitals Cleveland Medical Center, Cleveland
Providence Hospital, Southfield
St Joseph Mercy Oakland, Pontiac
Iowa Heart Center, West Des Moines
Aurora St. Luke's Medical Center, Milwaukee
University General Hospital of Thessaloniki (AHEPA), Thessaloniki
Minneapolis Heart Institute Foundation, Minneapolis
Barnes-Jewish Hospital, St Louis
Universitätsklinikum des Saarlandes, Homburg
Baylor Heart & Vascular Hospital, Dallas
Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH, Bad Krozingen
Universitätsklinikum Erlangen, Erlangen
Stanford Hospital and Clinics, Stanford
Oregon Health & Science University Hospital, Portland
Yale New Haven Hospital, New Haven
Saint Barnabas Medical Center, Livingston
The Miriam Hospital, Providence
St. George Hospital, Kogarah
Royal Perth, Perth
Hamilton Heath, Hamilton
St. Michael's Hospital, Toronto
Clinique Pasteur, Toulouse
Galway University Hospital, Galway
Higashi Takarazuka Satoh Hospital, Takarazuka
Shonan Kamakura General Hospital, Kamakura
Saiseikai Nakatsu Hospital, Osaka
Royal Bournemouth Hospital, Bournemouth
Cardiff and Vale University Health Board - University Hospital of Wales, Cardiff
Herzzentrum Leipzig, Universitätsklinik, Leipzig
Jichi Medical University Hospital, Shimotsuke
Mitsui Memorial Hospital, Chiyoda City
Royal Devon & Exeter NHS Foundation Trust, Exeter
Imperial College Healthcare NHS Trust, London
Lead Sponsor
Medtronic Vascular
INDUSTRY