RecruitingNCT07231757

The RADIANCE CED Study

The Recor Paradise System™ Hypertension Coverage With Evidence Development Study


Sponsor

ReCor Medical, Inc.

Enrollment

1,000 participants

Start Date

Nov 21, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 65 Years

Inclusion Criteria2

  • Adults aged ≥65 years with uncontrolled hypertension
  • Stable regimen of blood pressure-lowering medication

Exclusion Criteria4

  • Hypertension due to secondary causes
  • Prior renal denervation treatment
  • Pregnancy
  • End-stage renal disease, dialysis, or kidney transplant

Interventions

DEVICEUltrasound 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

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NCT07231757


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