The RADIANCE CED Study

ReCor Medical

Status: Enrolling

Conditions: Hypertension; Cardiovascular Diseases; Vascular Diseases

Treatments: Device: Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)

Study type: Observational

Funder types: Industry

Identifiers

NCT07231757

RADIANCE CED

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,000 participants in 2 patient groups

Exposure Group (uRDN + SOC)

Description:

A procedure or device code for the Paradise™ ultrasound renal denervation system (uRDN) and medication records indicating receipt of blood pressure-lowering medications.

Treatment:

Device: Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)

Comparator Group (SOC)

Description:

Medication records indicating receipt of blood pressure-lowering medications.