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

Recruiting in Palo Alto (17 mi)

+48 other locations

Overseen byAjay Kirtane, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: ReCor Medical, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ajay Kirtane, MD

Principal Investigator

Columbia University

Michel Azizi, MD, PhD

Principal Investigator

Hôpital Européen Georges-Pompidou

Eligibility Criteria

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.

Inclusion Criteria

Your kidneys need to be in good shape for the procedure, as shown by a recent high-quality scan.

I have been diagnosed with high blood pressure.

My blood pressure meets specific criteria even though I'm on medication or have tried lifestyle changes.

See 6 more

Exclusion Criteria

My kidney condition fits specific medical criteria.

I have specific kidney or heart conditions or a history of certain treatments.

Treatment Details

Interventions

Sham Procedure (Procedure)
The Paradise® Renal Denervation Ultrasound System (Renal Denervation System)

Trial OverviewThe 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).

Participant Groups

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.