RADIANCE CED: long-term outcomes after ultrasound renal denervation

The Recor Paradise System™ Hypertension Coverage With Evidence Development Study

This project will see if ultrasound renal denervation (using the Paradise system) lowers blood pressure over the long term in Medicare-age adults (65+) with uncontrolled hypertension by using their medical records.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: ReCor Medical, Inc. (Industry-sponsored)
• Locations: 1 site (Detroit, Michigan)
• Trial ID: NCT07231757 on ClinicalTrials.gov

What this trial studies

RADIANCE CED is a prospective observational study that collects electronic health record data from Medicare-eligible patients who underwent ultrasound renal denervation to track long-term blood pressure changes. The study focuses on adults aged 65 and older who have uncontrolled hypertension and are on a stable regimen of blood-pressure medications. Key exclusions include secondary hypertension, prior renal denervation, pregnancy, and end-stage renal disease or dialysis. The sponsor has obtained IRB exemption and individual hospital enrollment is not required, with data drawn to support generalizability to the broader Medicare population.

Who should consider this trial

Good fit: Adults aged 65 or older with uncontrolled hypertension who are on a stable blood-pressure medication regimen and do not have secondary hypertension, prior renal denervation, or end-stage kidney disease are the ideal candidates.

Not a fit: Patients with secondary causes of hypertension, prior renal denervation, end-stage renal disease or dialysis, pregnant people, and those younger than Medicare age are unlikely to gain relevant information from this study.

Why it matters

Potential benefit: If successful, this could demonstrate sustained blood-pressure lowering in older adults after ultrasound renal denervation and help expand adoption and insurance coverage, potentially reducing cardiovascular events.

How similar studies have performed: Previous randomized trials of renal denervation, including trials using the Paradise ultrasound system and catheter-based approaches, have shown promising blood-pressure reductions, though long-term real-world Medicare data are still limited.

Eligibility criteria

Common Inclusion Criteria:

* Adults aged ≥65 years with uncontrolled hypertension
* Stable regimen of blood pressure-lowering medication

Common Exclusion Criteria:

* Hypertension due to secondary causes
* Prior renal denervation treatment
* Pregnancy
* End-stage renal disease, dialysis, or kidney transplant

Where this trial is running

Detroit, Michigan

• Henry Ford St. John Hospital — Detroit, Michigan, United States (Recruiting)

Study contacts

• Principal investigator: Megan Coylewright, MD — Essentia Health
• Study coordinator: Helen Reeve-Stoffer, Ph.D

Conditions Hypertension; Cardiovascular Diseases; Vascular Diseases