Longitudinal Real-world Clinical Outcomes Study on Symplicity Renal Denervation (SPYRAL CARE)

Medtronic

Status: Enrolling

Conditions: Hypertension; Cardiovascular Diseases; Vascular Diseases

Treatments: Device: Renal Denervation (Symplicity Spyral™)

Study type: Observational

Funder types: Industry

Identifiers

NCT07174622

14467

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 2 patient groups

Symplicity RDN + SOC

Description:

Medicare patients on a stable antihypertension medication regimen and received RDN with a Symplicity RDN system

Treatment:

Device: Renal Denervation (Symplicity Spyral™)

SOC

Description:

Medicare patients on a stable antihypertension medication regimen