282 Participants Needed

Renal Denervation for High Blood Pressure

(RADIANCE-HTN Trial)

Recruiting at 48 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: ReCor Medical, Inc.
Must be taking: Antihypertensives
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Ajay J. Kirtane, MD, Cardiovascular ...

Ajay Kirtane, MD

Principal Investigator

Columbia University

MA

Michel Azizi, MD, PhD

Principal Investigator

Hôpital Européen Georges-Pompidou

Are You a Good Fit for This Trial?

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 5 more

Exclusion Criteria

My kidney condition fits specific medical criteria.
I have specific kidney or heart conditions or a history of certain treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the sham procedure or renal denervation treatment

2 months
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months
Multiple visits (in-person) at 6, 12, 24, and 36 months

What Are the Treatments Tested in This Trial?

Interventions

  • Sham Procedure
  • The Paradise® Renal Denervation Ultrasound System
Trial Overview 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).
How Is the Trial Designed?
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 Clinic Near You

Who Is Running the Clinical Trial?

ReCor Medical, Inc.

Lead Sponsor

Trials
11
Recruited
5,200+
Unbiased ResultsWe believe in providing patients with all the options.
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