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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.
Official title: The Recor Paradise System™ Hypertension Coverage With Evidence Development Study
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2025-11-21
Completion Date
2031-12-31
Last Updated
2026-01-09
Healthy Volunteers
No
Interventions
Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)
A catheter-based system that delivers ultrasound energy to the renal sympathetic nerves.
Locations (1)
Henry Ford St. John Hospital
Detroit, Michigan, United States