← Back to Search

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
Select...
I have been diagnosed with high blood pressure.
Select...
I am on 3 different blood pressure medicines including a diuretic and my blood pressure meets specific criteria.
Select...
I am between 18 and 75 years old.

RADIANCE-HTN Trial Timeline

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.

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
~32 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top