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

April 1, 2025 updated by: ReCor Medical, Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
225

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Centre Hospitalier Universitaire Saint-Pierre
  • France
      • Bordeaux, France, 33000
        • Hopital Saint André
      • Lille, France, 59000
        • CHRU de Lille
      • Paris, France, 75015
        • Hopital Europeen Georges-Pompidou (HEGP)
  • Germany
      • Erlangen, Germany, D-91054
        • University Clinic Erlangen
      • Homburg, Germany, D-66421
        • University Clinic of Saarland - Homburg
      • Karlsruhe, Germany, 76133
        • Klinikum Karlsruhe GmbH
      • Konstanz, Germany, D-78464
        • Klinikum Konstanz
      • Leipzig, Germany, D-04289
        • Herzzentrum Leipzig GmbH
      • Lübeck, Germany, D-23560
        • Sana Kliniken Lübeck GmbH
  • Ireland
      • Galway, Ireland, H91 YR71
        • University Hospital Galway
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus Medical Center
  • Switzerland
      • Geneva, Switzerland, 1211
        • Hôpitaux Universitaires Genève
  • United Kingdom
      • Bournemouth, United Kingdom, BH7 7DW
        • University Hospitals Dorset NHS Foundation Trust
      • Canterbury, United Kingdom, CT1 3NG
        • Kent & Canterbury Hospital
      • Cardiff, United Kingdom
        • University Hospital Wales
      • London, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital
    • Essex
      • Basildon, Essex, United Kingdom, SS16 5NL
        • The Cardiothoracic Centre Basildon University Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Cardiology PC
    • California
      • Los Angeles, California, United States, 940048
        • Cedars Sinai Medical Center
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Bridgeport Hospital
      • Stamford, Connecticut, United States, 06904
        • Stamford Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Washington
    • Florida
      • Gainesville, Florida, United States, 32605
        • The Cardiac and Vascular Institute
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Springfield, Illinois, United States, 62794
        • Southern Illinois University
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Heart and Vascular Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02120
        • The Brigham and Women's Hospital
    • Michigan
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Health System
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Regional Medical Center
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart & Lung Center
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center/NYPH
      • New York, New York, United States, 10075
        • Northwell Health Inc.
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • The University of North Carolina at Chapel Hill
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • The University Of Tennessee Health Science Center
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Previously or currently prescribed antihypertensive therapy
  • Average office BP ≥ 140/90 mmHg <180/120 mmHg while stable for at least 4 weeks on 0-2 classes of antihypertensive medication
  • Documented daytime ABP ≥ 135/85 mmHg and < 170/105 mmHg after 4-week washout/run-in period

Exclusion Criteria:

  • Lacks appropriate renal artery anatomy for treatment
  • Known, uncorrected causes of secondary hypertension other than sleep apnea
  • Type I diabetes mellitus or uncontrolled Type II diabetes
  • eGFR of <40
  • Brachial circumference ≥ 42 cm
  • Any history of cerebrovascular event or severe cardiovascular event, or history of stable or unstable angina within 12 months prior to consent
  • Repeat (>1) hospitalization for hypertensive crisis within 12 months prior to screening period, or any hospitalization for hypertensive crisis within 3 months prior to screening period
  • Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
  • Primary pulmonary hypertension
  • Night shift workers
  • Pregnant, nursing or planning to become pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Renal Denervation
Renal Angiogram and Renal Denervation (Paradise Renal Denervation System)
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.
Other Names:
  • Renal Denervation
  • Renal Angiogram
Sham Comparator: Sham Control
Renal Angiogram
Procedure: Renal Angiogram
Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of Major Adverse Events (MAE)
Time Frame: From baseline to 30 days post-procedure
From baseline to 30 days post-procedure
Change in average daytime ambulatory systolic BP
Time Frame: From baseline to 2 months post-procedure
From baseline to 2 months post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in average 24-hr ambulatory systolic BP
Time Frame: From baseline to 2 months post-procedure
From baseline to 2 months post-procedure
Change in average office systolic BP
Time Frame: From baseline to 2 months post-procedure
From baseline to 2 months post-procedure
Change in average home systolic BP
Time Frame: From baseline to 2 months post-procedure
From baseline to 2 months post-procedure
Change in average daytime ambulatory diastolic BP
Time Frame: From baseline to 2 months post-procedure
From baseline to 2 months post-procedure
Change in average 24-hr ambulatory diastolic BP
Time Frame: From baseline to 2 months post-procedure
From baseline to 2 months post-procedure
Change in average office diastolic BP
Time Frame: From baseline to 2 months post-procedure
From baseline to 2 months post-procedure
Change in average home diastolic BP
Time Frame: From baseline to 2 months post-procedure
From baseline to 2 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ReCor Medical, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ajay Kirtane, MD, SM, Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation
  • Principal Investigator: Prof. Michel Azizi, MD, PhD, Professor of Vascular Medicine, Hypertension Dept. and Clinical Investigation Center, Hôpital Européen Georges Pompidou

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 14, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RADIANCE II Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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