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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07174622
- Acronym / sponsor ID
- SPYRAL CARE / 14467
- Conditions
- Hypertension, Cardiovascular Diseases, Vascular Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symplicity RDN + SOC | – | Device: Renal Denervation (Symplicity Spyral™)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Enrolled in a Medicare plan
- Diagnosis of uncontrolled hypertension
- On a stable regimen of antihypertensive therapy
Key exclusion criteria (3 listed)
- A prior RDN procedure
- Diagnosis of secondary hypertension
- Any condition for which RDN is contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal Denervation (Symplicity Spyral™)Symplicity Spyral™ multi-electrode renal denervation system | Device | Symplicity RDN + SOC |
Primary outcome
Change in Office Systolic Blood Pressure (OSBP)
Time frame: 2 years
Change in OSBP at two years relative to baseline between matched treated and comparator cohorts.
1 secondary outcome
Time to Major Cardiovascular Event (MACE)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric A Secemsky, MD, MSc principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Cardiovascular Diseases, run by Medtronic Vascular at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kael Wherry, PhD, MS (612-229-0714, kael.wherry@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Office Systolic Blood Pressure (OSBP) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.