Cardiovascular Diseases, Hypertension, Vascular Diseases
Conditions
Brief 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.
Interventions
DEVICEUltrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)
A catheter-based system that delivers ultrasound energy to the renal sympathetic nerves.
Sponsors
ReCor Medical, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment for Changes in Blood Pressure | November 2025 - December 2029 |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of Adverse Cardiovascular and Cerebrovascular Event | November 2025 - December 2029 |
| Changes in Anti-Hypertensive Medication | November 2025 - December 2029 |
Countries
United States
Contacts
CONTACTHelen Reeve-Stoffer, Ph.D
CONTACTElizabeth A Sheehan, MLIS, MA
PRINCIPAL_INVESTIGATORMegan Coylewright, MD
Essentia Health
PRINCIPAL_INVESTIGATORAmir Kaki, MD
Ascension St. John Hospital
Outcome results
None listed