RecruitingNCT07231757

The RADIANCE CED Study

The Recor Paradise System™ Hypertension Coverage With Evidence Development Study


Sponsor

ReCor Medical, Inc.

Enrollment

1,000 participants

Start Date

Nov 21, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The RADIANCE CED study is a prospective observational study designed to evaluate the long-term effectiveness of ultrasound renal denervation in lowering blood pressure among patients with uncontrolled hypertension. Data will be collected from electronic health records (EHRs) of Medicare-eligible patients to support generalizability of outcomes to the broader Medicare population. Individual hospital enrollment is not required for this study and IRB exemption has been received by sponsor.


Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study (RADIANCE CED) is testing a procedure called renal denervation — a minimally invasive treatment that disrupts certain nerve signals to the kidneys — in older adults with high blood pressure that hasn't been controlled by medications. The goal is to see if this approach can better lower blood pressure. **You may be eligible if...** - You are 65 years or older - You have high blood pressure that is not well controlled despite taking medication - Your blood pressure medication doses have been stable **You may NOT be eligible if...** - Your high blood pressure is caused by another medical condition (secondary hypertension) - You have previously undergone renal denervation - You are pregnant - You have end-stage kidney disease, are on dialysis, or have had a kidney transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEUltrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)

A catheter-based system that delivers ultrasound energy to the renal sympathetic nerves.


Locations(1)

Henry Ford St. John Hospital

Detroit, Michigan, United States

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NCT07231757


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