A Study of the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN)

August 26, 2022 updated by: ReCor Medical, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Subjects with essential hypertension controlled on 1 or 2 antihypertensive medications or uncontrolled on 0-2 antihypertensive medications will be included in the RADIANCE Solo cohort while subjects with treatment resistant hypertension on a minimum of 3 antihypertensive medications will be included in the RADIANCE Trio cohort. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication (SOLO) or despite the presence of a stabilized, single pill, triple, fixed dose antihypertensive medication regimen (TRIO).

Study Type

Interventional

Enrollment (Anticipated)

292

Phase

  • 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, 1200
        • Cliniques Universitaires St Luc
  • France
      • Bordeaux, France, 33000
        • Hopital Saint-Andre - CHU Bordeaux
      • Lille, France, 59000
        • CHRU Lille - Institut Coeur Poumon
      • Lyon, France, 69004
        • Hôpital de La Croix Rousse
      • Paris, France, 75015
        • Hôpital Européen Georges-Pompidou
      • Toulouse, France, 31300
        • Clinique Pasteur
  • Germany
      • Dusseldorf, Germany, 40225
        • University Clinic Düsseldorf
      • Erlangen, Germany, 91054
        • University Clinic Erlangen
      • Freiburg, Germany, D-91054
        • Universitäts-Herzzentrum Freiburg-Bad Krozingen GmbH
      • Homburg, Germany, 66421
        • University Clinic of Saarland
      • Leipzig, Germany, 04289
        • Leipzig Heart Center
      • Lübeck, Germany, 23560
        • Sana Kliniken Lübeck GmbH
      • Mainz, Germany, 55131
        • Katholisches Klinikum Mainz
  • Netherlands
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Hospital
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus Medical Center
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht
  • Poland
      • Gdańsk, Poland, 80-952
        • Medical University of Gdansk
      • Warsaw, Poland, 04-628
        • Institute of Cardiology
  • United Kingdom
      • Basildon, United Kingdom
        • The Essex Cardiothoracic Centre - Basildon & Thurrock University Hospitals
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital (Wonford)
      • Hastings, United Kingdom, TN37 7RD
        • Conquest Hospital - Hastings
      • London, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospitals NHS Trust
    • England
      • Bournemouth, England, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
      • London, England, United Kingdom, SW7 2AZ
        • Imperial College London, Hammersmith Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • Los Angeles, California, United States, 90211
        • Cedars-Sinai Medical Center
      • Sacramento, California, United States, 95816
        • Sutter Health Medical Center
    • Connecticut
      • Stamford, Connecticut, United States, 06904
        • Stamford Hospital
    • Florida
      • Gainesville, Florida, United States, 32605
        • The Cardiac and Vascular Institute
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
    • Illinois
      • Springfield, Illinois, United States, 62794
        • Southern Illinois University Medicine
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Franciscan Health Indianapolis
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Heart and Vascular Insitute
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02120
        • The Brigham and Women's Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Institute for Heart& Vascular Health
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart and Lung Center
    • New York
      • New York, New York, United States, 10010
        • New York University School of Medicine
      • New York, New York, United States, 10032
        • Columbia University / NewYork Presbyterian Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7075
        • University of North Carolina at Chapel Hill School of Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
    • Texas
      • Plano, Texas, United States, 75093
        • The Heart Hospital Baylor Plano
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

TRIO and SOLO Inclusion Criteria:

  • 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

Solo Exclusion Criteria:

  • Renal artery anatomy on either side, ineligible for treatment including:

    • Main renal artery diameter < 4 mm and > 8 mm
    • Main renal artery length < 25 mm
    • A single functioning kidney
    • Presence of abnormal kidney (or secreting adrenal) tumors
    • Renal artery with aneurysm
    • Pre-existing renal stent or history of renal artery angioplasty
    • Prior renal denervation procedure
    • Fibromuscular disease of the renal arteries
    • Presence of renal artery stenosis of any origin ≥ 30%
    • Accessory arteries with diameter ≥ 2mm <4 mm and > 8 mm*
  • Evidence of active infection within 7 days of procedure
  • Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter
  • Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma Hb1Ac ≥ 9.0%)
  • Documented history of chronic active inflammatory bowel disorders such as Chrohn's disease or ulcerative colitis
  • eGFR of <40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula)
  • Brachial circumference ≥ 42 cm
  • Any history of cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident)
  • Any history of severe cardiovascular event (myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV)
  • Documented confirmed episode(s) of stable or unstable angina
  • Documented repeat (>1) hospitalization for hypertensive crisis within the prior 12 months
  • Prescribed to any standard antihypertensive of cardiovascular medication (e.g. beta blockers) for other chronic conditions (e.g. ischemic heart disease) such that discontinuation might pose serious risk to health
  • Documented history of persistent or permanent atrial tachyarrhythmia
  • Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator)
  • Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
  • Primary pulmonary hypertension
  • Documented contraindication or allergy to contrast medium not amenable to treatment
  • Limited life expectancy of < 1 year at the discretion of the Investigator
  • Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders (e.g. night shift workers)
  • Pregnant, nursing or planning to become pregnant (negative pregnancy test required, documented within a maximum of 7 days prior to procedure for all women of child bearing potential. Documentation of effective contraception is also required for women of child bearing potential) Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional Registries is acceptable)

TRIO Exclusion Criteria

  • Renal artery anatomy on either side, ineligible for treatment including:

    • Main renal artery diameter < 3.5 mm and > 8 mm
    • Main renal artery length < 20 mm
    • A single functioning kidney
    • Presence of abnormal kidney tumors
    • Renal artery with aneurysm
    • Pre-existing renal stent or history of renal artery angioplasty
    • Pre-existing aortic stent or history of aortic aneurysm
    • Prior renal denervation procedure
    • Fibromuscular disease of the renal arteries
    • Presence of renal artery stenosis of any origin ≥ 30%
    • Accessory arteries with diameter ≥2 mm <3.5 mm and > 8 mm*
  • Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter
  • Evidence of active infection within 7 days of procedure
  • Secondary hypertension not including sleep apnea (documented through clinical work up within the 12 months prior to consent- see protocol body for details)
  • Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma Hb1Ac ≥ 9.0%)
  • Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis
  • eGFR of <40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula)
  • Brachial circumference ≥ 42 cm
  • Any history of cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) within 3 months prior to consent
  • Any history of severe cardiovascular event (e.g. myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV) within 3 months prior to consent
  • Documented repeat (>1) hospitalization for hypertensive crisis within the prior 3 months
  • Documented confirmed episode(s) of unstable angina within 3 months prior to consent
  • Documented intolerance or contraindication for any of the antihypertensive drugs prescribed as a requirement of the study protocol
  • Prescribed to any standard anti-hypertensive CV medication (other than beta blockers) for other chronic conditions (e.g. ischemic heart disease) such that discontinuation might pose serious risk to health
  • Documented history of persistent or permanent atrial tachyarrhythmia
  • Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator)
  • Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
  • Primary pulmonary hypertension
  • Documented contraindication or allergy to contrast medium not amenable to treatment
  • Limited life expectancy of < 1 year at the discretion of the Investigator
  • Night shift workers
  • Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders
  • Pregnant, nursing or planning to become pregnant (documented negative pregnancy test required documented within a maximum of 7 days prior to procedure for all women of child bearing potential. Documentation of effective contraception is also required for women of child bearing potential)
  • Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional Registries is acceptable)

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound Renal Denervation
Subjects in the TRIO or SOLO cohorts that are randomized to treatment, will receive renal denervation following a renal angiogram
Device: 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.
Other Names:
  • renal denervation
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.
Device: 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.
Other Names:
  • renal angiogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean reduction 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

Outcome Measure
Measure Description
Time Frame
Reduction in average 24-hr/night-time ambulatory systolic BP
Time Frame: from baseline to 2 months post procedure
from baseline to 2 months post procedure
Reduction in average daytime/24-hr/night-time diastolic BP
Time Frame: from baseline to 2 months post procedure
from baseline to 2 months post procedure
All-cause mortality
Time Frame: from baseline to 36 months post-procedure
from baseline to 36 months post-procedure
Hypertensive or hypotensive emergency resulting in hospitalization
Time Frame: up to 36 months
up to 36 months
Hospitalization for heart failure
Time Frame: from baseline to 36 months post-procedure
from baseline to 36 months post-procedure
Stroke, transient ischemic attack, cerebrovascular accident
Time Frame: from baseline to 36 months post-procedure
from baseline to 36 months post-procedure
Acute myocardial infarction
Time Frame: from baseline to 36 months post-procedure
from baseline to 36 months post-procedure
End stage renal disease
Time Frame: from baseline to 36 months post-procedure
from baseline to 36 months post-procedure
Renal artery or vascular complications requiring intervention
Time Frame: from baseline to 36 months post-procedure
from baseline to 36 months post-procedure
Significant embolic events resulting in end organ damage
Time Frame: from baseline to 1 month and 36 months post-procedure
from baseline to 1 month and 36 months post-procedure
Procedure related pain lasting > 2 days
Time Frame: from baseline to 1 month and 36 months post-procedure
from baseline to 1 month and 36 months post-procedure
Acute renal injury
Time Frame: from baseline to 1 month and 36 months post-procedure
from baseline to 1 month and 36 months post-procedure
Significant (>50%) and severe (>75%) new onset renal stenosis
Time Frame: from baseline to 6, 12, 24 and 36 months post-procedure
as diagnosed by duplex ultrasound and confirmed by renal CTA/MRA or as diagnosed/confirmed by study defined renal CTA/MRA at 12 months
from baseline to 6, 12, 24 and 36 months post-procedure
Major access site complications
Time Frame: from baseline to 1 month and 36 months post-procedure
from baseline to 1 month and 36 months post-procedure

Collaborators and Investigators

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

Sponsor

ReCor Medical, Inc.

Investigators

  • Principal Investigator: Michel Azizi, MD, PhD, Hôpital Européen Georges-Pompidou
  • Principal Investigator: Ajay J Kirtane, M.D, Columbia University

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

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

March 1, 2016

Primary Completion (Actual)

September 1, 2020

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

January 4, 2016

First Submitted That Met QC Criteria

January 5, 2016

First Posted (Estimate)

January 7, 2016

Study Record Updates

Last Update Posted (Actual)

August 29, 2022

Last Update Submitted That Met QC Criteria

August 26, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN 0777

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

to be determined

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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