The RADIANCE CED Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System).
- Who it may be relevant to
- Registry conditions: Hypertension, Cardiovascular Diseases, Vascular Diseases. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Recor Paradise System™ Hypertension Coverage With Evidence Development Study
Overview
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.
Interventions
- Device Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)
A catheter-based system that delivers ultrasound energy to the renal sympathetic nerves.
Primary outcome measures
- Assessment for Changes in Blood Pressure [Time frame: November 2025 - December 2029]
Secondary outcome measures (2)
- Occurrence of Adverse Cardiovascular and Cerebrovascular Event [Time frame: November 2025 - December 2029]
- Changes in Anti-Hypertensive Medication [Time frame: November 2025 - December 2029]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Henry Ford Hospital — Detroit
- Henry Ford St. John Hospital — Detroit
Identifiers
NCT: NCT07231757 · RADIANCE CED