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Renal Denervation System

Renal Denervation for High Blood Pressure (RADIANCE-HTN Trial)

N/A

Waitlist Available

Led By Ajay J Kirtane, M.D

Research Sponsored by ReCor Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented history of essential hypertension

TRIO Cohort: Meeting specific blood pressure criteria while on a stable regimen of at least 3 antihypertensive medications of different classes including a diuretic

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 6, 12, 24 and 36 months post-procedure

Awards & highlights

RADIANCE-HTN Trial Summary

This trial is designed to study whether a new renal denervation system is effective and safe in two groups of people with hypertension.

Who is the study for?

This trial is for adults aged 18-75 with high blood pressure who can follow the study plan. Participants must have a history of hypertension and suitable renal anatomy. The SOLO group includes those on blood pressure meds or lifestyle changes, while the TRIO group requires being on at least three different blood pressure medications including a diuretic.Check my eligibility

What is being tested?

The study tests the Paradise Renal Denervation System against a sham (fake) procedure to see if it's effective and safe in lowering blood pressure. It has two parts: one for patients less dependent on medication (SOLO) and another for those needing multiple drugs (TRIO).See study design

What are the potential side effects?

While specific side effects are not listed here, procedures like renal denervation could potentially cause discomfort, bruising or bleeding at the access site, reactions to contrast media used in imaging, or rare complications related to catheter-based interventions.

RADIANCE-HTN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with high blood pressure.

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I am on 3 different blood pressure medicines including a diuretic and my blood pressure meets specific criteria.

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I am between 18 and 75 years old.

RADIANCE-HTN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 6, 12, 24 and 36 months post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 6, 12, 24 and 36 months post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 6, 12, 24 and 36 months post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean reduction in average daytime ambulatory systolic BP

Secondary outcome measures

Acute myocardial infarction

Acute renal injury

All-cause mortality

+11 more

RADIANCE-HTN Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ultrasound Renal DenervationExperimental Treatment1 Intervention

Subjects in the TRIO or SOLO cohorts that are randomized to treatment, will receive renal denervation following a renal angiogram

Group II: Sham ProcedurePlacebo Group1 Intervention

For subjects in TRIO or SOLO cohorts that randomize to the sham procedure, the diagnostic renal angiogram intervention will be considered the sham procedure.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

ReCor Medical, Inc.Lead Sponsor

10 Previous Clinical Trials

4,884 Total Patients Enrolled

Ajay J Kirtane, M.DPrincipal InvestigatorColumbia University

Michel Azizi, MD, PhDPrincipal InvestigatorHôpital Européen Georges-Pompidou

2 Previous Clinical Trials

209 Total Patients Enrolled

Media Library

The Paradise® Renal Denervation Ultrasound System (Renal Denervation System) Clinical Trial Eligibility Overview. Trial Name: NCT02649426 — N/A

High Blood Pressure Research Study Groups: Sham Procedure, Ultrasound Renal Denervation

High Blood Pressure Clinical Trial 2023: The Paradise® Renal Denervation Ultrasound System Highlights & Side Effects. Trial Name: NCT02649426 — N/A

The Paradise® Renal Denervation Ultrasound System (Renal Denervation System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02649426 — N/A

High Blood Pressure Patient Testimony for trial: Trial Name: NCT02649426 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals over 60 years old eligible to partake in this research?

"According to the trial's requirements, eligible participants must be aged 18 or older but not exceed 75 years of age."

Answered by AI

Can I participate in this research endeavor?

"This trial is aimed at individuals aged 18 to 75 living with a vascular disease. To be eligible, potential participants must sign the consent form as well as ensure they meet all study requirements. Furthermore, a recent (no more than one year old) Computed Tomography Angiogram or Magnetic Resonance Angiogram of suitable renal anatomy will need to be provided in order for them to qualify."

Answered by AI

Are there any particular healthcare facilities conducting research on this trial?

"This clinical trial is actively enrolling patients through 24 discrete medical centres, with multiple sites in New Orleans, Philadelphia and New york. To reduce the need for travel associated with this study it would be ideal to identify a clinic near you."

Answered by AI

Is enrollment being accepted into this clinical experiment at present?

"Data hosted on clinicaltrials.gov indicates that this investigation is not presently enrolling patients, despite being posted in March of 2016 and last updated in August of 2022. Fortunately, there are 836 other studies actively searching for participants at the moment."

Answered by AI