The RADIANCE CED Study

January 7, 2026 updated by: ReCor Medical, Inc.

The Recor Paradise System™ Hypertension Coverage With Evidence Development Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Recruiting
        • Henry Ford St. John Hospital
        • Contact:
          • Amir Kaki, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults aged ≥ 65 years with uncontrolled hypertension

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)
A catheter-based system that delivers ultrasound energy to the renal sympathetic nerves.
Other Names:
  • Paradise™ ultrasound renal denervation system
Comparator Group (SOC)
Medication records indicating receipt of blood pressure-lowering medications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment for Changes in Blood Pressure
Time Frame: November 2025 - December 2029
November 2025 - December 2029

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of Adverse Cardiovascular and Cerebrovascular Event
Time Frame: November 2025 - December 2029
November 2025 - December 2029
Changes in Anti-Hypertensive Medication
Time Frame: November 2025 - December 2029
November 2025 - December 2029

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ReCor Medical, Inc.

Investigators

  • Principal Investigator: Amir Kaki, MD, Ascension St. John Hospital
  • Principal Investigator: Megan Coylewright, MD, Essentia Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

September 15, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Estimated)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RADIANCE CED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data (IPD) available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

Clinical Trials on Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe