Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension on Standard Medical Therapy (SPYRAL HTN-ON MED)

Status: Active, not recruiting
Location: See all (56) 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 presence of up to three standard antihypertensive medications.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: No
View:

• Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg when receiving a medication regimen of one, two, or three antihypertensive medication classes.

• Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and < 170 mmHg.

Locations
United States
Alabama
Heart Center Research, LLC
Huntsville
California
Stanford Hospital and Clinics
Stanford
Connecticut
Yale New Haven Hospital
New Haven
Washington, D.c.
Washington DC VA Medical Center
Washington
Florida
Baptist Medical Center Jacksonville
Jacksonville
Memorial Hospital 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
Weill Cornell Medical College/The New York Presbyterian Hospital
New York
Ohio
University Hospitals Cleveland Medical Center
Cleveland
Oregon
Oregon Health & Science University Hospital
Portland
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
St. George Hospital
Kogarah
Alfred Hospital
Melbourne
Royal Perth
Perth
Austria
Klinikum Wels-Grieskirchen
Wels
Canada
Hamilton Heath
Hamilton
St. Michael's Hospital
Toronto
France
Clinique Pasteur
Toulouse
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
Shonan Kamakura General Hospital
Kamakura City
Saiseikai Nakatsu Hospital
Osaka
Jichi Medical University Hospital
Shimotsuke
Higashi Takarazuka Satoh Hospital
Takarazuka
United Kingdom
Royal Bournemouth Hospital
Bournemouth
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: July 2015
Estimated Completion Date: July 2026
Participants
Target number of participants: 337
Treatments
Experimental: Renal Denervation
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Sham Comparator: Sham Procedure
Renal angiography
Authors
Junya Shte, Saturo Otsuji, Pam Sigmund, Raymond Townsend, George D. Dangas, Brent McLaurin, Anton Lishmanov, Fidel Garcia, Bryan Batson, Carl Lomboy, Thomas Noel, Aravinda Nanjundappa, James Campbell, Alan Yeung, Sabino Torre, Jasvindar Singh, Beth Chia, Brian Jefferson, Suhail Allaqaband, Mehdi Shishehbor, Mohannad Bisharat, James Choi, Rachel Onsrud, Susan Steigerwalt, Costin Ionescu, Randolph Rough, Manesh Patel, Michael Remetz, David Lee, Dmitriy Feldman, Adrian Ma, Yale Wang, William Bachinsky, Marc Litt, Robert Wilkins, Shukri David, Herbert Aronow, David Kandzari, Joshua Krasnow, Magdi Ghali, Bharat Gummadi, Barry Bertolet, Kirit Patel, Anthony Walton, Rasha Al Lamee, Felix Mahfoud, Tanja Böhme, Victoria Buciuceanu, Bodo Cremers, Udo Desch, Alexandros Kasiakogias, Philipp Lurz, Axel Schmid, Agnes Jumar, Mark Gilchrist, Robert Höllriegel, Sebastian Ewen, Elias Noory, Clare Bent, Andrew Sharp, Richard D'Souza, Benjamin Honton, Thomas Zeller, Michael Böhm, David Meredith, Christian Ott, Katja Wolf, Jolly Sanjit, Neil Chapman, Markus Suppan, Anjani Rao, George Mangos, John Graham, Junya Shite, Daniel Keene, Jiro Aoki, James Howard, Chandan Devireddy, Cara East, Harsh Golwala, Justin Davies, Markus Schlaich, Konstantinos P Tsioufis, Ulrich Beschoner, David Thompson, Dimitriadis Kyriakos, Konstantinidis Dimitrios, Avneet Singh, Christopher Regan, Christopher Cook, Faisal Sharif, Karl Fengler, Debbie Cohen, Shigeru Saito, Sanjit Jolly, Antonios Ziakas, Matthew Shun-Shin, Kazuomi Kario, Eirini Andrikou
Related Therapeutic Areas
Sponsors
Leads: Medtronic Vascular

This content was sourced from clinicaltrials.gov

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