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

Inclusion Criteria3

  • Enrolled in a Medicare plan
  • Diagnosis of uncontrolled hypertension
  • On a stable regimen of antihypertensive therapy

Exclusion Criteria3

  • A prior RDN procedure
  • Diagnosis of secondary hypertension
  • Any condition for which RDN is contraindicated

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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