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
This trial does not accept healthy volunteersQualifiers
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 population
Adults aged ≥ 65 years with uncontrolled hypertension
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)
DeviceA catheter-based system that delivers ultrasound energy to the renal sympathetic nerves.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Exposure Group (uRDN + SOC)1 intervention
Group B: Comparator Group (SOC)0 interventions
Trial outcomes
Primary outcomes
1
Assessment for Changes in Blood Pressure
Time frame
November 2025 - December 2029Secondary outcomes
1
Occurrence of Adverse Cardiovascular and Cerebrovascular Event
Time frame
November 2025 - December 20292
Changes in Anti-Hypertensive Medication
Time frame
November 2025 - December 2029Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov