Long-term outcomes of Symplicity renal denervation for uncontrolled hypertension in Medicare patients
Official title: 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
Run by Medtronic Vascular · NCT07174622 · Data updated 2026-11-12
This project will see if adding the Symplicity renal denervation procedure to usual care lowers blood pressure over two years in Medicare patients with uncontrolled hypertension.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Medtronic Vascular Industry-sponsored |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | October 28, 2025 |
| Main results expected | June 2029 |
| Study ends | June 2029 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07174622 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Medicare enrollees who have uncontrolled hypertension, are on a stable antihypertensive regimen, have no prior renal denervation, and have no diagnoses or conditions that contraindicate the procedure.
✕Probably not a fit
Patients with secondary hypertension, a prior RDN procedure, contraindications to RDN, or who are not enrolled in Medicare will not be represented and are unlikely to benefit from the findings of this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational, non-interventional study of Medicare beneficiaries with uncontrolled hypertension treated with the Symplicity renal denervation system plus standard of care or with standard of care alone. Researchers will use de-identified, longitudinal administrative claims linked with electronic health record data to compare outcomes without requiring new procedures or clinic visits. The primary comparison focuses on change in office systolic blood pressure at two years, and a secondary analysis will describe major adverse cardiac events over the same period. Patients are identified through submitted claims or encounter data to CMS, and the study is overseen by a central IRB, with no required local IRB review for individual hospitals.
Why it matters
Potential benefit: If successful, the study could show that renal denervation plus usual care produces greater and durable blood pressure reduction and possibly fewer cardiac events in older patients with uncontrolled hypertension.
How similar studies have gone: Prior randomized trials and registries of modern renal denervation systems have shown mixed but increasingly positive blood pressure reductions, so this real-world Medicare analysis builds on a growing evidence base.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Eric A Secemsky, MD, MSc — Beth Israel Deaconess Medical Center
- Study coordinator: Kael Wherry, PhD, MS
- Email: kael.wherry@medtronic.com
- Phone: 612-229-0714
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.