The Recor Paradise System™ Hypertension Coverage With Evidence Development Study
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:
• Adults aged ≥65 years with uncontrolled hypertension
• Stable regimen of blood pressure-lowering medication
Locations
United States
Michigan
Henry Ford St. John Hospital
RECRUITING
Detroit
Contact Information
Primary
Helen Reeve-Stoffer, Ph.D
hreeve-stoffer@recormedical.com
650-542-7700
Backup
Elizabeth A Sheehan, MLIS, MA
liz.sheehan@recormedical.com
650-542-7700
Time Frame
Start Date: 2025-11-21
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 1000
Treatments
Exposure Group (uRDN + SOC)
A procedure or device code for the Paradise™ ultrasound renal denervation system (uRDN) and medication records indicating receipt of blood pressure-lowering medications.
Comparator Group (SOC)
Medication records indicating receipt of blood pressure-lowering medications.
Related Therapeutic Areas
Sponsors
Leads: ReCor Medical, Inc.