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
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Enrolled in a Medicare plan
• Diagnosis of uncontrolled hypertension
• On a stable regimen of antihypertensive therapy
Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Contact Information
Primary
Kael Wherry, PhD, MS
kael.wherry@medtronic.com
612-229-0714
Time Frame
Start Date: 2025-10-28
Estimated Completion Date: 2029-06
Participants
Target number of participants: 1000
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Medtronic Vascular