The RADIANCE CED Study
Recruiting · NCT07231757 · Observational (researchers observe without assigning treatment) · Lead sponsor: ReCor Medical, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)
What this trial is about
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.
Who can take part
Age range
65 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
2 locations listed across 1 US state.
- Henry Ford Hospital - Detroit, Michigan, United States
- Henry Ford St. John Hospital - Detroit, Michigan, United States