Longitudinal Real-world Clinical Outcomes Study on Symplicity Renal Denervation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Renal Denervation (Symplicity Spyral™).
- Who it may be relevant to
- Registry conditions: Hypertension, Cardiovascular Diseases, Vascular Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device Renal Denervation (Symplicity Spyral™)
Symplicity Spyral™ multi-electrode renal denervation system
Primary outcome measures
- Change in Office Systolic Blood Pressure (OSBP) [Time frame: 2 years]
Secondary outcome measures (1)
- Time to Major Cardiovascular Event (MACE) [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Enrolled in a Medicare plan
- Diagnosis of uncontrolled hypertension
- On a stable regimen of antihypertensive therapy
Exclusion criteria
- A prior RDN procedure
- Diagnosis of secondary hypertension
- Any condition for which RDN is contraindicated
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Beth Israel Deaconess Medical Center — Boston
Identifiers
NCT: NCT07174622 · 14467