The RADIANCE CED Study
NCT07231757 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000
Last updated 2026-01-09
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
Interventions
- DEVICE
-
Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)
A catheter-based system that delivers ultrasound energy to the renal sympathetic nerves.
Sponsors & Collaborators
-
ReCor Medical, Inc.
lead INDUSTRY
Principal Investigators
-
Megan Coylewright, MD · Essentia Health
-
Amir Kaki, MD · Ascension St. John Hospital
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-21
- Primary Completion
- 2029-12-31
- Completion
- 2031-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Renal Denervation in Chronic Kidney Disease - RDN-CKD Study
NCT04264403 ·Status: COMPLETED ·Phase: NA
-
Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment Clinical Trial
NCT01392196 ·Status: TERMINATED ·Phase: NA
-
Renal Denervation in Patients With Chronic Heart Failure
NCT02085668 ·Status: WITHDRAWN ·Phase: NA
-
Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension
NCT00753116 ·Status: COMPLETED ·Phase: PHASE1
-
Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study B
NCT03519360 ·Status: WITHDRAWN ·Phase: NA
-
Sympathetic Mapping/ Ablation of Renal Nerves Trial - Hemodialysis
NCT04872114 ·Status: UNKNOWN ·Phase: NA
-
Post-Market Observational Study of Intra-Renal Drug Delivery
NCT00716404 ·Status: WITHDRAWN
-
Impact on Quality of Life of Symptoms Routine E-monitoring Among Dialysis Patients.
NCT06257134 ·Status: RECRUITING ·Phase: NA
-
Renal Denervation to Improve Outcomes in Patients With End-stage Renal Disease
NCT02021019 ·Status: COMPLETED ·Phase: NA
-
Effect at 6 Months of Renal Denervation in Chronic Heart Failure d'Insuffisance Cardiaque
NCT02471729 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotension
NCT01749761 ·Status: COMPLETED ·Phase: NA
-
Study to Evaluate the Safety and Efficacy of the Renal Assist Device in Patients With Acute Renal Failure
NCT00280072 ·Status: TERMINATED ·Phase: PHASE2
-
Evaluation of Electrostimulation Program During Dialysis Sessions in Chronic Renal Failure Patients
NCT01282554 ·Status: COMPLETED ·Phase: NA
-
Adjusting Fluid Removal Based on Blood Volume in Hemodialysis: A Randomized Study
NCT01988181 ·Status: COMPLETED ·Phase: NA
-
Evaluation of a Pathway on the Evolution of Renal Function in Patients With Advanced Chronic Kidney Disease
NCT06219798 ·Status: RECRUITING
-
OneShot Renal Denervation Registry
NCT01844037 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Feasibility Study to Evaluate Renal Denervation Using Focused Ultrasound
NCT01704170 ·Status: COMPLETED ·Phase: NA
-
Control Of Fluid Balance Guided by Body Composition Monitoring in Patients on PeritoneAl dialySiS
NCT01887262 ·Status: COMPLETED ·Phase: NA
-
Efficacy Study of the Addition of Bemiparin to Icodextrin Solution in Peritoneal Dialysis Patients (Bemidextrina)
NCT00369096 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of Biocompatibility and Performances of 4 Dialyzers in Different Mode Treatments
NCT03262272 ·Status: COMPLETED ·Phase: NA
-
Efficacy of Live Online Course Mindfulness Program on Perceived Fatigue in Hemodialysis Patients
NCT07054112 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Detection of Lung Pathologies Among Dialysis Patients Using Pulsenmore MC™ Device - Feasibility Study
NCT07028060 ·Status: COMPLETED ·Phase: NA
-
Mechanisms and Treatment of Intradialytic Hypertension - Sodium
NCT01371890 ·Status: COMPLETED
-
Sham Controlled Clinical Trial of Renal Denervation in Patients With Resistant Hypertension
NCT02444442 ·Status: COMPLETED ·Phase: NA
-
Intradialytic Exercise With Blood Flow Restriction in Hemodialysis Patients
NCT07269379 ·Status: RECRUITING ·Phase: NA