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A Study of the ReCor Medical Paradise System in Clinical Hypertension

NCT02649426 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2026-04-21

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • ReCor Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Michel Azizi, MD, PhD · Hôpital Européen Georges-Pompidou

  • Ajay J Kirtane, M.D · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2020-09-30
Completion
2027-05-31

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Netherlands
  • Poland
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02649426 on ClinicalTrials.gov