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The RADIANCE CED Study
The Recor Paradise Systemâ„¢ Hypertension Coverage With Evidence Development Study
Who can join
Ages 65 and older · All sexes
Full 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
About the study
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.
What is being tested
- Ultrasound Renal Denervation (Paradiseâ„¢ Ultrasound Renal Denervation (uRDN) System) (device)
Sponsor: ReCor Medical, Inc. · Participants: 1,000 · Started: Nov 21, 2025
Contact the study team
- Helen Reeve-Stoffer, Ph.D · Phone: 650-542-7700
- Elizabeth A Sheehan, MLIS, MA · Phone: 650-542-7700
Official record on ClinicalTrials.gov — NCT07231757
Locations in the U.S.
| Michigan | Henry Ford Hospital, Detroit Henry Ford St. John Hospital, Detroit |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.