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
This trial does not accept healthy volunteersQualifiers
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 population
The study population will consist of patients enrolled in Medicare treated with RDN or on stable antihypertension management in any US location.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Renal Denervation (Symplicity Spyral™)
DeviceSymplicity Spyral™ multi-electrode renal denervation system
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Symplicity RDN + SOC1 intervention
Group B: SOC0 interventions
Trial outcomes
Primary outcomes
1
Change in Office Systolic Blood Pressure (OSBP)
Change in OSBP at two years relative to baseline between matched treated and comparator cohorts.
Time frame
2 yearsSecondary outcomes
1
Time to Major Cardiovascular Event (MACE)
The secondary outcome is time to MACE over 2 years for the matched treated and comparator cohorts. MACE is defined as the composite of non-fatal stroke, non-fatal myocardial infarction, and all-cause death.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov