CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 282 enrolled
Drug / intervention
The Paradise® Renal Denervation Ultrasound System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02649426
NCT02649426N/AActive
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The "RADIANCE-HTN" Study. A Study of the ReCor Medical Paradise System in Clinical Hypertension

ReCor Medical, Inc.·interventional·Posted Jan 7, 2016·Updated Apr 21, 2026

In Brief

A clinical study evaluating The Paradise® Renal Denervation Ultrasound System and Sham Procedure for Hypertension and Vascular Diseases. Active but no longer recruiting, targeting 282 participants across 49 sites in 7 countries.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Vascular Diseases
CountriesBelgium, France, Germany, Netherlands, Poland, United Kingdom, United States
Collaborators--

Timeline

N/AActive
201620172018201920202021202220232024202520262027
First PostedJan 7, 2016
Enrollment StartMar 1, 2016
Primary CompletionSep 1, 2020
Study CompletionMay 1, 2027
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 10.5 years ago

Interventions

The Paradise® Renal Denervation Ultrasound Systemdevice

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.

Sham Proceduredevice

Randomization will occur following the diagnostic renal angiogram. For blinded patients randomized to control, the diagnostic renal angiogram will be considered the sham procedure.