The RADIANCE CED Study

Part of paid clinical trials in Detroit, Michigan.

Sponsor
ReCor Medical, Inc.
Study ID
NCT07231757
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System) — DEVICE
    A catheter-based system that delivers ultrasound energy to the renal sympathetic nerves.

Study Details

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.

Key Dates

Start date
Nov 21, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2031

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Exposure Group (uRDN + SOC)
    A procedure or device code for the Paradise™ ultrasound renal denervation system (uRDN) and medication records indicating receipt of blood pressure-lowering medications.
  • Arm: Comparator Group (SOC)
    Medication records indicating receipt of blood pressure-lowering medications.

Primary Outcome Measure

Assessment for Changes in Blood Pressure [ Time Frame: November 2025 - December 2029 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford St. John HospitalDetroitMichigan48236
Amir Kaki, MD

Find similar trials in Detroit, MI

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Henry Ford St. John Hospital· Detroit, MI

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