Status:
RECRUITING
Longitudinal Real-world Clinical Outcomes Study on Symplicity Renal Denervation
Lead Sponsor:
Medtronic Vascular
Conditions:
Hypertension
Cardiovascular Diseases
Eligibility:
All Genders
65+ years
Brief Summary
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 u...
Detailed Description
The SPYRAL CARE study is an observational, non-interventional study of the Medicare population with uncontrolled hypertension treated with either the Symplicity RDN system plus standard of care (SOC) ...
Eligibility Criteria
Inclusion
- ≥12 months of history of continuous health plan enrollment with medical and prescription coverage
- Age ≥65 and enrolled in a Medicare plan
- Stable antihypertension regimen and on ≥1 antihypertensive medications
- Diagnosis of uncontrolled hypertension (\> 140/90 mm Hg)
Exclusion
- A prior RDN procedure
- Diagnosis of secondary hypertension
- Any condition for which RDN is contraindicated
Key Trial Info
Start Date :
October 28 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT07174622
Start Date
October 28 2025
End Date
June 1 2029
Last Update
October 31 2025
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215