Longitudinal Real-world Clinical Outcomes Study on Symplicity Renal Denervation
Recruiting · NCT07174622 · Observational (researchers observe without assigning treatment) · Lead sponsor: Medtronic Vascular
View the official record on ClinicalTrials.gov →Interventions studied
Renal Denervation (Symplicity Spyral™)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed across 1 US state.
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States