The Recor Paradise System™ Hypertension Coverage With Evidence Development Study
ReCor Medical, Inc.
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
- Age range
- 65+ years
- Sex
- All
- Healthy volunteers
- No
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
- DeviceUltrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)
A catheter-based system that delivers ultrasound energy to the renal sympathetic nerves.
Location
- Henry Ford St. John HospitalDetroit, Michigan