RADIANCE CED: long-term outcomes after ultrasound renal denervation
Official title: The Recor Paradise System™ Hypertension Coverage With Evidence Development Study
Run by ReCor Medical, Inc. · NCT07231757 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | ReCor Medical, Inc. Industry-sponsored |
| Locations | 2 sites (Detroit, Michigan and 1 other locations) |
| Status | Recruiting |
| Started | November 21, 2025 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2031 |
| Registry record updated | July 16, 2026 |
| Trial ID | NCT07231757 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Henry Ford Hospital
Detroit, Michigan, United States Recruiting -
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
- Email: hreeve-stoffer@recormedical.com
- Phone: 650-542-7700
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.