Longitudinal Real-world Clinical Outcomes Study on Symplicity Renal Denervation

Not yet recruiting

• Conditions: Hypertension; Cardiovascular Diseases; Vascular Diseases

• Registration Number: NCT07174622
• Lead Sponsor: Medtronic Vascular

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.

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 Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-11
• Study First Posted: 2025-09-16
• Last Update Submitted: 2025-09-19
• Last Update Posted: 2025-09-23
• Study Start: 2025-10-08
• Primary Completion: 2029-06
• Study Completion: 2029-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• ≥12 months of history of continuous health plan enrollment with medical and prescription coverage
• Age ≥65 and enrolled in a Medicare plan
• Stable antihypertension regimen and on ≥1 antihypertensive medications
• Diagnosis of uncontrolled hypertension (> 140/90 mm Hg)

Exclusion Criteria

• A prior RDN procedure
• Diagnosis of secondary hypertension
• Any condition for which RDN is contraindicated

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Office Systolic Blood Pressure (OSBP)	2 years	Change in OSBP at two years relative to baseline between matched treated and comparator cohorts.

Secondary Outcome Measures

Name	Time	Method
Time to Major Cardiovascular Event (MACE)	2 years	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.

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States