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

NAActive, not recruitingINTERVENTIONAL
Enrollment

225

Participants

Timeline

Start Date

December 14, 2018

Primary Completion Date

December 21, 2022

Study Completion Date

July 31, 2027

Conditions
HypertensionVascular DiseasesCardiovascular Diseases
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.

Trial Locations (47)

1000

Centre Hospitalier Universitaire Saint-Pierre, Brussels

1211

Hôpitaux Universitaires Genève, Geneva

10032

Columbia University Medical Center/NYPH, New York

10075

Northwell Health Inc., New York

15213

University of Pittsburgh Medical Center, Pittsburgh

19104

University of Pennsylvania Health System, Philadelphia

20010

MedStar Washington, Washington D.C.

27599

The University of North Carolina at Chapel Hill, Chapel Hill

29425

Medical University of South Carolina, Charleston

30308

Emory University Hospital Midtown, Atlanta

32605

The Cardiac and Vascular Institute, Gainesville

33000

Hôpital Saint André, Bordeaux

35211

Cardiology PC, Birmingham

37232

Vanderbilt University, Nashville

38163

The University of Tennessee Health Science Center, Memphis

44195

Cleveland Clinic, Cleveland

49684

Munson Medical Center, Traverse City

55407

Minneapolis Heart Institute Foundation, Minneapolis

59000

CHRU de Lille, Lille

60611

Northwestern University, Chicago

62794

Southern Illinois University, Springfield

64111

Saint Luke's Health System, Kansas City

70121

Ochsner Heart and Vascular Institute, New Orleans

75015

Hôpital Européen Georges-Pompidou (HEGP), Paris

76133

Klinikum Karlsruhe GmbH, Karlsruhe

84132

University of Utah, Salt Lake City

89502

Renown Regional Medical Center, Reno

98122

Swedish Medical Center, Seattle

940048

Cedars Sinai Medical Center, Los Angeles

06610

Bridgeport Hospital, Bridgeport

06904

Stamford Hospital, Stamford

02120

The Brigham and Women's Hospital, Boston

08015

Deborah Heart & Lung Center, Browns Mills

07601

Hackensack University, Hackensack

D-91054

University Clinic Erlangen, Erlangen

D-66421

University Clinic of Saarland - Homburg, Homburg

D-78464

Klinikum Konstanz, Konstanz

D-04289

Herzzentrum Leipzig GmbH, Leipzig

D-23560

Sana Kliniken Lübeck GmbH, Lübeck

H91 YR71

University Hospital Galway, Galway

3015 GD

Erasmus Medical Center, Rotterdam

SS16 5NL

The Cardiothoracic Centre Basildon University Hospital, Basildon

BH7 7DW

University Hospitals Dorset NHS Foundation Trust, Bournemouth

CT1 3NG

Kent & Canterbury Hospital, Canterbury

Unknown

University Hospital Wales, Cardiff

EC1A 7BE

St Bartholomew's Hospital, London

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

All Listed Sponsors
lead

ReCor Medical, Inc.

INDUSTRY