Longitudinal Real-world Clinical Outcomes Study on Symplicity Renal Denervation
SPYRAL CARE
Real-world Clinical Outcomes in Medicare Patients With Hypertension Treated With Symplicity Renal Denervation Plus Standard of Care Versus Standard of Care in Integrated EHR and Claims Data
1 other identifier
observational
1,000
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2025
CompletedFirst Posted
Study publicly available on registry
September 16, 2025
CompletedStudy Start
First participant enrolled
October 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
April 22, 2026
April 1, 2026
3.6 years
September 11, 2025
April 21, 2026
Conditions
Outcome Measures
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.
2 years
Secondary Outcomes (1)
Time to Major Cardiovascular Event (MACE)
2 years
Study Arms (2)
Symplicity RDN + SOC
Medicare patients on a stable antihypertension medication regimen and received RDN with a Symplicity RDN system
SOC
Medicare patients on a stable antihypertension medication regimen
Interventions
Symplicity Spyral™ multi-electrode renal denervation system
Eligibility Criteria
The study population will consist of patients enrolled in Medicare treated with RDN or on stable antihypertension management in any US location.
You may qualify if:
- Enrolled in a Medicare plan
- Diagnosis of uncontrolled hypertension
- On a stable regimen of antihypertensive therapy
You may not qualify if:
- A prior RDN procedure
- Diagnosis of secondary hypertension
- Any condition for which RDN is contraindicated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Eric A Secemsky, MD, MSc
Beth Israel Deaconess Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2025
First Posted
September 16, 2025
Study Start
October 28, 2025
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
June 1, 2029
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share