NCT02649426

A Study of the ReCor Medical Paradise System in Clinical Hypertension

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 282 (actual)
• Sponsor: ReCor Medical, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Hypertension
• Vascular Diseases

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2020-09-01
• Completion: 2025-05-01
• First posted: 2016-01-07
• Last updated: 2024-06-28
• Results posted: 2024-06-28

Locations

49 sites across 7 countries: United States, Belgium, France, Germany, Netherlands, Poland, United Kingdom