RecruitingNCT07174622

Longitudinal Real-world Clinical Outcomes Study on Symplicity Renal Denervation

Real-world Clinical Outcomes in Medicare Patients With Hypertension Treated With Symplicity Renal Denervation Plus Standard of Care Versus Standard of Care in Integrated EHR and Claims Data


Sponsor

Medtronic Vascular

Enrollment

1,000 participants

Start Date

Oct 28, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This observational study will assess the long-term effectiveness of the RDN procedure for lowering blood pressure in Medicare patients with uncontrolled hypertension. This research will be conducted using de-identified electronic health records (EHR) and administrative health insurance claims data. Patients are enrolled through the submission of claims or encounter data to CMS.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking real-world outcomes for people who have had a procedure called renal denervation (RDN) — a minimally invasive treatment that uses radio waves to calm overactive nerves around the kidneys to help lower blood pressure. **You may be eligible if...** - You are enrolled in a Medicare health plan - You have been diagnosed with uncontrolled high blood pressure (hypertension) - You are currently on a steady regimen of blood pressure medications **You may NOT be eligible if...** - You have already had a renal denervation procedure in the past - Your high blood pressure is caused by another identifiable condition (secondary hypertension) - You have a medical condition that makes renal denervation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERenal Denervation (Symplicity Spyral™)

Symplicity Spyral™ multi-electrode renal denervation system


Locations(1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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NCT07174622


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