Longitudinal Real-world Clinical Outcomes Study on Symplicity Renal Denervation

The SPYRAL CARE study is an observational, non-interventional study of the Medicare population with uncontrolled hypertension treated with either the Symplicity RDN system plus standard of care (SOC) or with SOC alone. SOC reflects active management of hypertension. The study will evaluate real-world clinical outcomes by examining deidentified, longitudinal data from administrative health insurance claims linked with EHR. The primary objective is to assess the change in office systolic blood pressure at two years for patients treated with Symplicity RDN plus SOC compared to similar patients receiving SOC alone. The secondary objective is to describe major adverse cardiac events over a two-year period in both groups. The study analysis is subject to a central Institutional Review Board (IRB) review. However, individual hospitals are not engaged in research, and local IRB oversight is not necessary.

Inclusion criteria

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

Exclusion criteria

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