The RADIANCE CED Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorReCor Medical, Inc.
About this trial
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
Qualifiers
Adults aged ≥65 years with uncontrolled hypertension
Stable regimen of blood pressure-lowering medication
Disqualifiers
Hypertension due to secondary causes
Prior renal denervation treatment
Pregnancy
End-stage renal disease, dialysis, or kidney transplant
Trial design
Treatments tested in this trial
- Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)
Treatment groups
1,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov