Longitudinal Real-world Clinical Outcomes Study on Symplicity Renal Denervation
Purpose
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.
Conditions
- Hypertension
- Cardiovascular Diseases
- Vascular Diseases
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Symplicity RDN + SOC | Medicare patients on a stable antihypertension medication regimen and received RDN with a Symplicity RDN system |
|
| SOC | Medicare patients on a stable antihypertension medication regimen |
|
Recruiting Locations
Boston, Massachusetts 02215
More Details
- Status
- Recruiting
- Sponsor
- Medtronic Vascular
Detailed Description
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.