Observational Study of Symplicity Renal Denervation for Uncontrolled High Blood Pressure

This observational study is looking at how well the Symplicity Spyral™ renal denervation (RDN) system works to lower blood pressure in people with uncontrolled high blood pressure (hypertension). RDN is a procedure that uses a device to treat nerves in the kidney. Researchers will compare changes in your office blood pressure after two years if you receive Symplicity Spyral™ RDN plus your usual care, versus just usual care alone. This study uses existing medical records and insurance claims data, so you would not have any extra appointments or procedures. You may be eligible if you are enrolled in Medicare, have uncontrolled high blood pressure, and are already taking blood pressure medication. The study aims to enroll 1000 participants, but its current status is unclear.

Study design
This is an observational study comparing 1000 Medicare patients who receive the Symplicity RDN system plus standard care to similar patients receiving standard care alone.
What's involved
This study uses existing medical records and insurance claims data. You would not have any extra appointments, procedures, or tests.
Compensation
Not stated in the trial record.
Follow-up
Researchers will look at your blood pressure changes and major adverse cardiac events over a two-year period.

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NCT07174622

Longitudinal Real-world Clinical Outcomes Study on Symplicity Renal Denervation

Recruiting
Not specifiedAges 18+Observational
Medtronic Vascular
~1,000 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:Renal Denervation (Symplicity Spyral™)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Office Systolic Blood Pressure (OSBP)
Measured over 2 years
Hypertension
Cardiovascular Diseases
Vascular Diseases
1 sites across 1 states
Massachusetts1
  • Eric A Secemsky, MD, MSc · PRINCIPAL_INVESTIGATOR · Beth Israel Deaconess Medical Center

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

A prior RDN procedure
Diagnosis of secondary hypertension
Any condition for which RDN is contraindicated
  • Change in Office Systolic Blood Pressure (OSBP)2 years

    Change in OSBP at two years relative to baseline between matched treated and comparator cohorts.