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Longitudinal Real-world Clinical Outcomes Study on Symplicity Renal Denervation

NCT ID: NCT07174622

Last Updated: 2025-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-28

Study Completion Date

2029-06-30

Brief Summary

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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

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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

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Hypertension Cardiovascular Diseases Vascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Symplicity RDN + SOC

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

Renal Denervation (Symplicity Spyral™)

Intervention Type DEVICE

Symplicity Spyral™ multi-electrode renal denervation system

SOC

Medicare patients on a stable antihypertension medication regimen

No interventions assigned to this group

Interventions

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Renal Denervation (Symplicity Spyral™)

Symplicity Spyral™ multi-electrode renal denervation system

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Vascular

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric A Secemsky, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kael Wherry, PhD, MS

Role: CONTACT

Phone: 612-229-0714

Email: [email protected]

Facility Contacts

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Eric A. Secemsky, MD, MSc

Role: primary

Other Identifiers

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14467

Identifier Type: -

Identifier Source: org_study_id