HypertensionSPYRAL CARENCT07174622
Longitudinal Real-world Clinical Outcomes Study on Symplicity Renal Denervation
An observational study of Hypertension and Cardiovascular Diseases, run by Medtronic Vascular at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Cardiovascular Diseases, Vascular Diseases
- What is being tested?
- Renal Denervation (Symplicity Spyral™)
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2025to Jun 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of patients enrolled in Medicare treated with RDN or on stable antihypertension management in any US location.
Who may be able to join
- Enrolled in a Medicare plan
- Diagnosis of uncontrolled hypertension
- On a stable regimen of antihypertensive therapy
Who cannot join
- A prior RDN procedure
- Diagnosis of secondary hypertension
- Any condition for which RDN is contraindicated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Eric A. Secemsky, MD, MSc, 617-632-7753, esecemsk@bidmc.harvard.edu
About this study
Official title: 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
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.
Read the 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) 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.
- Conditions
- Hypertension, Cardiovascular Diseases, Vascular Diseases
- Being tested
- Renal Denervation (Symplicity Spyral™)
- Medical subject headings
- Hypertension, Cardiovascular Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Denervation (Symplicity Spyral™)Device
Symplicity Spyral™ multi-electrode renal denervation system
| Study group | Role | What they receive |
|---|---|---|
| Symplicity RDN + SOC | Medicare patients on a stable antihypertension medication regimen and received RDN with a Symplicity RDN system Receives: Device: Renal Denervation (Symplicity Spyral™) | |
| SOC | Medicare patients on a stable antihypertension medication regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Office Systolic Blood Pressure (OSBP)
Change in OSBP at two years relative to baseline between matched treated and comparator cohorts.
Measured: 2 years
Secondary 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start28 Oct 2025
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric A Secemsky, MD, MSc, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174622
- Sponsor's protocol ID
- 14467
- Acronym
- SPYRAL CARE
- Status last verified
- Oct 2026
- First submitted
- 11 Sep 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No