Recruiting

Ultrasound Renal Denervation

Sponsor:

ReCor Medical, Inc.

Code:

NCT07231757

Conditions

Hypertension

Cardiovascular Diseases

Vascular Diseases

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Hypertension

Cardiovascular Diseases

Vascular Diseases

Study ID

NCT07231757

Start date

Nov 21, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Comparator Group (SOC)

Medication records indicating receipt of blood pressure-lowering medications.

Interventions

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

A catheter-based system that delivers ultrasound energy to the renal sympathetic nerves.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Helen Reeve-Stoffer, Ph.D

650-542-7700hreeve-stoffer@recormedical.com

Elizabeth A Sheehan, MLIS, MA

650-542-7700liz.sheehan@recormedical.com

Locations

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Michelle Butcher

586-202-0376mbutche1@hfhs.org

Principal Investigator:

Herbert Aronow, MD

Henry Ford St. John Hospital

Recruiting

Detroit, Michigan, United States, 48236

More Information

Sponsor

ReCor Medical, Inc.

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ReCor Medical, Inc. on 2026-07-16.