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ACTIVE NOT RECRUITING
NCT03614260
NA

The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension

Sponsor: ReCor Medical, Inc.

View on ClinicalTrials.gov

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

DEVICE

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.

PROCEDURE

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