Longitudinal Real-world Clinical Outcomes Study on Symplicity Renal Denervation

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Medtronic Vascular
Study ID
NCT07174622
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Renal Denervation (Symplicity Spyral™) — DEVICE
    Symplicity Spyral™ multi-electrode renal denervation system

Study Details

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.

Key Dates

Start date
Oct 28, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Symplicity RDN + SOC
    Medicare patients on a stable antihypertension medication regimen and received RDN with a Symplicity RDN system
  • Arm: SOC
    Medicare patients on a stable antihypertension medication regimen

Primary Outcome Measure

Change in Office Systolic Blood Pressure (OSBP) [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Eric A. Secemsky, MD, MSc
[email protected]
617-632-7753

Find similar trials in Boston, MA

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Beth Israel Deaconess Medical Center· Boston, MA

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