Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications (SPYRAL PIVOTAL - SPYRAL HTN-OFF MED)
Status: Completed
Location: See all (47) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the absence of antihypertensive medications.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
View:
• Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and \<180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg after being off medications.
• Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and \< 170 mmHg.
• Individual is willing to discontinue current antihypertensive medications.
Locations
United States
Alabama
Heart Center Research, LLC
Huntsville
Arizona
Honor Health Research Institute
Scottsdale
California
Kaiser Permanente LA Medical Center
Los Angeles
Stanford Hospital and Clinics
Stanford
Connecticut
Yale New Haven Hospital
New Haven
Florida
Baptist Medical Center Jacksonville
Jacksonville
Tallahassee Research Institute
Tallahassee
Georgia
Emory University Hospital Midtown
Atlanta
Piedmont Heart Institute
Atlanta
Iowa
Iowa Heart Center
West Des Moines
Kentucky
University of Kentucky
Lexington
Michigan
St Joseph Mercy Oakland
Pontiac
Providence Hospital
Southfield
Minnesota
Minneapolis Heart Institute Foundation
Minneapolis
Missouri
Barnes-Jewish Hospital
Saint Louis
Mississippi
Hattiesburg Clinic
Hattiesburg
Cardiology Associates Research LLC
Tupelo
North Carolina
Duke University Medical Center
Durham
New Jersey
Saint Barnabas Medical Center
Livingston
New York
North Shore University Hospital
Manhasset
Mount Sinai Medical Center
New York
Ohio
University Hospitals Cleveland Medical Center
Cleveland
Pennsylvania
PinnacleHealth Cardiovascular Institute
Harrisburg
Hospital of the University of Pennsylvania
Philadelphia
Rhode Island
The Miriam Hospital
Providence
South Carolina
AnMed Health
Anderson
Tennessee
Centennial Medical Center
Nashville
Texas
Baylor Heart & Vascular Hospital
Dallas
Wisconsin
Aurora St. Luke's Medical Center
Milwaukee
West Virginia
Charleston Area Medical Center
Charleston
Other Locations
Australia
Alfred Hospital
Melbourne
Austria
Klinikum Wels-Grieskirchen
Wels
Canada
Institut de cardiologie de Montréal / Montreal Heart Institute
Montréal
St. Michael's Hospital
Toronto
Germany
Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
Bad Krozingen
Universitätsklinikum Erlangen
Erlangen
Universitätsklinikum des Saarlandes
Homburg
Herzzentrum Leipzig, Universitätsklinik
Leipzig
Sana Kliniken Lübeck
Lübeck
Greece
Hippokration General Hospital of Athens
Athens
University General Hospital of Thessaloniki (AHEPA)
Thessaloniki
Ireland
Galway University Hospital
Galway
Japan
Mitsui Memorial Hospital
Chiyoda
Jichi Medical University Hospital
Shimotsuke
United Kingdom
Cardiff and Vale University Health Board - University Hospital of Wales
Cardiff
Royal Devon & Exeter NHS Foundation Trust
Exeter
Imperial College Healthcare NHS Trust
London
Time Frame
Start Date: 2015-06
Completion Date: 2023-10-25
Participants
Target number of participants: 366
Treatments
Experimental: Renal Denervation
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Sham_comparator: Sham Procedure
Renal angiography
Authors
Chandan Devireddy, James Campbell, George D. Dangas, Brent McLaurin, Fidel Garcia, Bryan Batson, Carl Lomboy, Thomas Noel, Robert Wilkins, Basma Merhi, Alan Yeung, Sabino Torre, Jasvindar Singh, Brian Jefferson, Suhail Allaqaband, Mehdi Shishehbor, James Choi, Bimal Padaliya, Anjani Rao, Susan Steigerwalt, Robert Burke, Randolph Rough, Michael Remetz, Adrian Ma, Yale Wang, William Bachinsky, Shukri David, Herbert Aronow, David Kandzari, Christopher Regan, Magdi Ghali, Somjot Brar, Barry Bertolet, Felix Mahfoud, Tanja Böhme, Bodo Cremers, Alexandros Kasiakogias, Axel Schmid, Agnes Jumar, Mark Gilchrist, Robert Höllriegel, Sebastian Ewen, Elias Noory, Andrew Sharp, David Meredith, Aravinda Nanjundappa, Joshua Krasnow, Costin Ionescu, Eirini Andrikou, Neil Chapman, John Graham, Daniel Keene, Justin Davies, Christian Ott, James Howard, Antonios Ziakas, Matthew Shun-Shin, Konstantinos P Tsioufis, Thomas Zeller, Faisal Sharif, Christopher Cook, Philipp Lurz, Jiro Aoki, Karl Fengler
Related Therapeutic Areas
Sponsors
Leads: Medtronic Vascular