The RADIANCE CED Study
Purpose
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.
Conditions
- Hypertension
- Cardiovascular Diseases
- Vascular Diseases
Eligibility
- Eligible Ages
- Over 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
Recruiting Locations
Henry Ford Hospital
Detroit, Michigan 48202
Detroit, Michigan 48202
Henry Ford St. John Hospital
Detroit, Michigan 48236
Detroit, Michigan 48236
Contact:
Amir Kaki, MD
Amir Kaki, MD
More Details
- Status
- Recruiting
- Sponsor
- ReCor Medical, Inc.