282
Participants
Start Date
March 31, 2016
Primary Completion Date
September 30, 2020
Study Completion Date
May 31, 2025
The Paradise® Renal Denervation Ultrasound System
Randomization will occur following the diagnostic renal angiogram. Blinded patients randomized to treatment will receive the renal denervation procedure using the Paradise System to deliver ultrasound energy to thermally ablate and disrupt the renal sympathetic nerves while sparing the renal arterial wall.
Sham Procedure
Randomization will occur following the diagnostic renal angiogram. For blinded patients randomized to control, the diagnostic renal angiogram will be considered the sham procedure.
Cliniques Universitaires St Luc, Brussels
New York University School of Medicine, New York
Columbia University / NewYork Presbyterian Hospital, New York
University of Pennsylvania, Philadelphia
Sana Kliniken Lübeck GmbH, Lübeck
Medical University of South Carolina, Charleston
Emory University Hospital Midtown, Atlanta
Clinique Pasteur, Toulouse
The Cardiac and Vascular Institute, Gainesville
Hôpital Saint-André - CHU Bordeaux, Bordeaux
University of Alabama at Birmingham, Birmingham
Vanderbilt University, Nashville
University Clinic Dusseldorf, Düsseldorf
University Hospitals Cleveland Medical Center, Cleveland
Cleveland Clinic, Cleveland
Franciscan Health Indianapolis, Indianapolis
Katholisches Klinikum Mainz, Mainz
Minneapolis Heart Institute, Minneapolis
CHRU Lille - Institut Coeur Poumon, Lille
Southern Illinois University Medicine, Springfield
University Clinic of Saarland, Homburg
Hôpital de la Croix Rousse, Lyon
Ochsner Heart and Vascular Insitute, New Orleans
Hôpital Européen Georges-Pompidou, Paris
The Heart Hospital Baylor Plano, Plano
University of Utah, Salt Lake City
Renown Institute for Heart& Vascular Health, Reno
Cedars-Sinai Medical Center, Los Angeles
University Clinic Erlangen, Erlangen
Sutter Health Medical Center, Sacramento
Stamford Hospital, Stamford
Massachusetts General Hospital, Boston
The Brigham and Women's Hospital, Boston
Deborah Heart and Lung Center, Browns Mills
University of North Carolina at Chapel Hill School of Medicine, Chapel Hill
Universitäts-Herzzentrum Freiburg-Bad Krozingen GmbH, Freiburg im Breisgau
Leipzig Heart Center, Leipzig
Maastricht University Hospital, Maastricht
Erasmus Medical Center, Rotterdam
University Medical Center Utrecht, Utrecht
Medical University of Gdansk, Gdansk
Institute of Cardiology, Warsaw
Royal Bournemouth Hospital, Bournemouth
Imperial College London, Hammersmith Hospital, London
The Essex Cardiothoracic Centre - Basildon & Thurrock University Hospitals, Basildon
Royal Devon and Exeter Hospital (Wonford), Exeter
Conquest Hospital - Hastings, Hastings
St Bartholomew's Hospital, London
Nottingham University Hospitals NHS Trust, Nottingham
ReCor Medical, Inc.
INDUSTRY