Longitudinal Real-world Clinical Outcomes Study on Symplicity Renal Denervation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedtronic Vascular
About this trial
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 criteria
Qualifiers
Enrolled in a Medicare plan
Diagnosis of uncontrolled hypertension
On a stable regimen of antihypertensive therapy
Disqualifiers
A prior RDN procedure
Diagnosis of secondary hypertension
Any condition for which RDN is contraindicated
Trial design
Treatments tested in this trial
- Renal Denervation (Symplicity Spyral™)
Treatment groups
1,000 Participants
are divided into 2 treatment groupsLocations
1Beth Israel Deaconess Medical Center02215, BostonMassachusetts, United States
Sponsors and collaborators
Medtronic Vascular
Lead sponsor
Source ClinicalTrials.gov