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The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension
Sponsor: ReCor Medical, Inc.
Summary
The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
225
Start Date
2018-12-14
Completion Date
2027-07
Last Updated
2025-04-04
Healthy Volunteers
No
Interventions
Paradise Renal Denervation System
Following renal angiogram according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
Renal Angiogram
Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure.
Locations (47)
Cardiology PC
Birmingham, Alabama, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Stamford Hospital
Stamford, Connecticut, United States
MedStar Washington
Washington D.C., District of Columbia, United States
The Cardiac and Vascular Institute
Gainesville, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Southern Illinois University
Springfield, Illinois, United States
Ochsner Heart and Vascular Institute
New Orleans, Louisiana, United States
The Brigham and Women's Hospital
Boston, Massachusetts, United States
Munson Medical Center
Traverse City, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Saint Luke's Health System
Kansas City, Missouri, United States
Renown Regional Medical Center
Reno, Nevada, United States
Deborah Heart & Lung Center
Browns Mills, New Jersey, United States
Hackensack University
Hackensack, New Jersey, United States
Columbia University Medical Center/NYPH
New York, New York, United States
Northwell Health Inc.
New York, New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
The University of Tennessee Health Science Center
Memphis, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Utah
Salt Lake City, Utah, United States
Swedish Medical Center
Seattle, Washington, United States
Centre Hospitalier Universitaire Saint-Pierre
Brussels, Belgium
Hôpital Saint André
Bordeaux, France
CHRU de Lille
Lille, France
Hôpital Européen Georges-Pompidou (HEGP)
Paris, France
University Clinic Erlangen
Erlangen, Germany
University Clinic of Saarland - Homburg
Homburg, Germany
Klinikum Karlsruhe GmbH
Karlsruhe, Germany
Klinikum Konstanz
Konstanz, Germany
Herzzentrum Leipzig GmbH
Leipzig, Germany
Sana Kliniken Lübeck GmbH
Lübeck, Germany
University Hospital Galway
Galway, Ireland
Erasmus Medical Center
Rotterdam, Netherlands
Hôpitaux Universitaires Genève
Geneva, Switzerland
The Cardiothoracic Centre Basildon University Hospital
Basildon, Essex, United Kingdom
University Hospitals Dorset NHS Foundation Trust
Bournemouth, United Kingdom
Kent & Canterbury Hospital
Canterbury, United Kingdom
University Hospital Wales
Cardiff, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom