NCT07231757Recruiting
The RADIANCE CED Study
ReCor Medical, Inc.
Start Date
11/21/2025
Completion Date
12/31/2031
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 Criteria
Age Range: 65 years to No maximum
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
Interventions
DEVICE
Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)
Conditions
HypertensionCardiovascular DiseasesVascular Diseases
Locations
Henry Ford Hospital
Detroit, Michigan 48202
United States
Henry Ford St. John Hospital
Detroit, Michigan 48236
United States