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Recruiting

NCT Number: NCT07231757

The RADIANCE CED 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.

Recruiting

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Henry Ford Hospital, Detroit, Michigan, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Other names: Paradise™ ultrasound renal denervation system

Primary outcomes

  1. Assessment for Changes in Blood Pressure

    Time frame: November 2025 - December 2029

Secondary outcomes

  1. Occurrence of Adverse Cardiovascular and Cerebrovascular Event

    Time frame: November 2025 - December 2029

  2. Changes in Anti-Hypertensive Medication

    Time frame: November 2025 - December 2029

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth A Sheehan, MLIS, MA

CONTACT

[email protected]

650-542-7700

Helen Reeve-Stoffer, Ph.D

CONTACT

[email protected]

650-542-7700

Sponsors and collaborators

Lead sponsor

ReCor Medical, Inc.

Industry

Registry information

Official study title

The Recor Paradise System™ Hypertension Coverage With Evidence Development Study

Important dates

Study start
2025
Primary completion
2029
Study completion
2031
First posted
Nov 17, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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