The RADIANCE-HTN Study. A Study of the ReCor Medical Paradise System in Clinical Hypertension

Status: Active, not recruiting
Location: See all (49) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

RADIANCE-HTN is a randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO) designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in two distinct populations of hypertensive subjects.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: No
View:

• Appropriately signed and dated informed consent

• Age ≥18 and ≤75 years at time of consent

• Documented history of essential hypertension

• SOLO Cohort only: Either an average seated office BP < 180/110 mmHg at screening visit while on a stable regimen of 1 or 2 antihypertensive medications for at least 4 weeks prior to consent or an average seated office BP ≥ 140/90 mmHg <180/110 mmHg despite lifestyle measures on no antihypertensive medications

• TRIO Cohort only: Average seated office BP ≥ 140/90 mmHg at screening visit while on a stable regimen of at least 3 antihypertensive medications of different classes including a diuretic for at least 4 weeks prior to consent

• Documented daytime ABP ≥ 135/85 mmHg and < 170/105 mmHg after 4-week washout/run-in period (SOLO cohort) or after 4-week stabilization period (TRIO cohort)

• Suitable renal anatomy compatible with the renal denervation procedure and documented by renal CTA or MRA of good quality performed within one year prior to consent (a CTA or MRA will be obtained in patients without a recent (≤1 year) renal imaging)

• Able and willing to comply with all study procedures

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
California
Cedars-Sinai Medical Center
Los Angeles
Sutter Health Medical Center
Sacramento
Connecticut
Stamford Hospital
Stamford
Florida
The Cardiac and Vascular Institute
Gainesville
Georgia
Emory University Hospital Midtown
Atlanta
Illinois
Southern Illinois University Medicine
Springfield
Indiana
Franciscan Health Indianapolis
Indianapolis
Louisiana
Ochsner Heart and Vascular Insitute
New Orleans
Massachusetts
Massachusetts General Hospital
Boston
The Brigham and Women's Hospital
Boston
Minnesota
Minneapolis Heart Institute
Minneapolis
North Carolina
University of North Carolina at Chapel Hill School of Medicine
Chapel Hill
New Jersey
Deborah Heart and Lung Center
Browns Mills
Nevada
Renown Institute for Heart& Vascular Health
Reno
New York
Columbia University / NewYork Presbyterian Hospital
New York
New York University School of Medicine
New York
Ohio
Cleveland Clinic
Cleveland
University Hospitals Cleveland Medical Center
Cleveland
Pennsylvania
University of Pennsylvania
Philadelphia
South Carolina
Medical University of South Carolina
Charleston
Tennessee
Vanderbilt University
Nashville
Texas
The Heart Hospital Baylor Plano
Plano
Utah
University of Utah
Salt Lake City
Other Locations
Belgium
Cliniques Universitaires St Luc
Brussels
France
Hôpital Saint-André - CHU Bordeaux
Bordeaux
CHRU Lille - Institut Coeur Poumon
Lille
Hôpital de la Croix Rousse
Lyon
Hôpital Européen Georges-Pompidou
Paris
Clinique Pasteur
Toulouse
Germany
University Clinic Dusseldorf
Dusseldorf
University Clinic Erlangen
Erlangen
Universitäts-Herzzentrum Freiburg-Bad Krozingen GmbH
Freiburg
University Clinic of Saarland
Homburg
Leipzig Heart Center
Leipzig
Sana Kliniken Lübeck GmbH
Lübeck
Katholisches Klinikum Mainz
Mainz
Netherlands
Maastricht University Hospital
Maastricht
Erasmus Medical Center
Rotterdam
University Medical Center Utrecht
Utrecht
Poland
Medical University of Gdansk
Gdańsk
Institute of Cardiology
Warsaw
United Kingdom
The Essex Cardiothoracic Centre - Basildon & Thurrock University Hospitals
Basildon
Royal Bournemouth Hospital
Bournemouth
Royal Devon and Exeter Hospital (Wonford)
Exeter
Conquest Hospital - Hastings
Hastings
Imperial College London, Hammersmith Hospital
London
St Bartholomew's Hospital
London
Nottingham University Hospitals NHS Trust
Nottingham
Time Frame
Start Date: March 2016
Estimated Completion Date: May 2025
Participants
Target number of participants: 292
Treatments
Experimental: Ultrasound Renal Denervation
Subjects in the TRIO or SOLO cohorts that are randomized to treatment, will receive renal denervation following a renal angiogram
Sham Comparator: Sham Procedure
For subjects in TRIO or SOLO cohorts that randomize to the sham procedure, the diagnostic renal angiogram intervention will be considered the sham procedure.
Authors
Florian Radar, Jaroslaw Jaguszewski, Tom Todoran, Doug Drachman, Mathur Anthony, Richard Bala, Jessie Goldman, Sudha Iyer, Richard Ericson, Ajay K. Jain, James S Jenkins, Amit Patel, Gery Tomassoni, David Zidar, Laura Mauri, Josephine Abraham, Jan Basile, Eric Powers, David Calhoun, Matheen Khuddus, Robert Fishman, Kevin Scully, Ajay Kirtane, Mehdi Shishehbor, Isabelle Hatfield, Todd Adams, David Hsi, James Gainer, Atul Chugh, James O'Meara, David Lee, Michael Bloch, Yale L Wang, John Flack, Richard Re, Kintur Sanghvi, Michael Cash, Jackson Wright, Pei-Hsiu Huang, Pete Fong, Tyrone Collins, Joseph Garasic, William Maddox, Michael Jones, Bryan Wells, Somjot Brar, Randall Zusman, Robert Schwartz, John P Reilly, David Roberts, Christopher Caputo, Scott Biedermann, Athul Pathak, Sachin Jadhav, Pascal Delsart, Anthony Mathur, Felix Mahfoud, Michel Azizi, Hibba Kurdi, Roland Schmieder, Constantin von zur Mühlen, Uwadiegwu W. Okoroafor, Armin Grawe, Philipp Lurz, Pierre Lantelme, Thomas Keeble, Denise Kämpfner, Jeremy Sayer, Johannes Höhne, Andreas Liebrich, David Beckett, Clare Bent, Andrew Sharp, Anthony Watkinson, Richard J. D'Souza, Joachim Weil, Marc Sapoval, Nicholas Robinson, Terry Levy, Philippe Gosse, Sabine Genth-Zotz, Illie Barb, Jose Tafur, Sebastian Grundmann, Dennis Wolf, Tyler Richmond, Neil Chapman, Christopher Bajzer, Rajan Patel, Robert Gerber, Jakub Sobolewski, Darrel Francis, Chandan Devireddy, George Stouffer, Janice Lea, Abraham A Kroon, Peter J Blankestijn, Justin Davies, Adam Witkowski, Jose Powell, Gerhard A. Mueller, Alexandre Persu, Melvin Lobo, Sripal Bangalore, Dagmara Hering, Joost Daemen, Debbie Cohen, Lars C Rump, Christoph Olivier, Manish Saxena, Tom McElderry, Naomi Fisher, David J. Collier, Srini Potluri
Related Therapeutic Areas
Sponsors
Leads: ReCor Medical, Inc.

This content was sourced from clinicaltrials.gov

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