An observational study in Hypertension, Cardiovascular Diseases and Vascular Diseases, sponsored by Medtronic Vascular. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Medtronic Vascular (part of Medtronic) · Observational
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.
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) or with SOC alone. SOC reflects active management of hypertension. The study will evaluate real-world clinical outcomes by examining deidentified, longitudinal data from administrative health insurance claims linked with EHR. The primary objective is to assess the change in office systolic blood pressure at two years for patients treated with Symplicity RDN plus SOC compared to similar patients receiving SOC alone. The secondary objective is to describe major adverse cardiac events over a two-year period in both groups. The study analysis is subject to a central Institutional Review Board (IRB) review. However, individual hospitals are not engaged in research, and local IRB oversight is not necessary.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 350 across 1,163 observational studies indexed under Hypertension.
Browse Hypertension studies →Medtronic Vascular is the lead sponsor of 60 studies on the registry; 7 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will consist of patients enrolled in Medicare treated with RDN or on stable antihypertension management in any US location.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Medicare patients on a stable antihypertension medication regimen and received RDN with a Symplicity RDN system
Device: Renal Denervation (Symplicity Spyral™)
Medicare patients on a stable antihypertension medication regimen
Symplicity Spyral™ multi-electrode renal denervation system
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 years
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 years
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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