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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposure Group (uRDN + SOC) | A procedure or device code for the Paradiseā¢ 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Renal Denervation (Paradiseā¢ Ultrasound Renal Denervation (uRDN) System) | Device | A catheter-based system that delivers ultrasound energy to the renal sympathetic nerves. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment for Changes in Blood Pressure | November 2025 - December 2029 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Adverse Cardiovascular and Cerebrovascular Event | November 2025 - December 2029 | |
| Changes in Anti-Hypertensive Medication | November 2025 - December 2029 |
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Common Inclusion Criteria:
Common Exclusion Criteria:
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Adults aged ā„ 65 years with uncontrolled hypertension
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helen Reeve-Stoffer, Ph.D | Contact | 650-542-7700 | hreeve-stoffer@recormedical.com | |
| Elizabeth A Sheehan, MLIS, MA | Contact | 650-542-7700 | liz.sheehan@recormedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Megan Coylewright, MD | Essentia Health | Principal Investigator |
| Amir Kaki, MD | Ascension St. John Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford St. John Hospital | Recruiting | Detroit | Michigan | 48236 | United States |
There is no plan to make individual participant data (IPD) available.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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