Recruiting

RDN

Sponsor:

Medtronic Vascular

Code:

NCT07174622

Conditions

Hypertension

Cardiovascular Diseases

Vascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Renal Denervation (Symplicity Spyral™)

Study Details

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.

Conditions

Hypertension

Cardiovascular Diseases

Vascular Diseases

Study ID

NCT07174622

Start date

Oct 28, 2025

Status verified date

Apr, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Symplicity RDN + SOC

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

SOC

Medicare patients on a stable antihypertension medication regimen

Interventions

Renal Denervation (Symplicity Spyral™)

Symplicity Spyral™ multi-electrode renal denervation system

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kael Wherry, PhD, MS

612-229-0714kael.wherry@medtronic.com

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Eric A. Secemsky, MD, MSc

617-632-7753esecemsk@bidmc.harvard.edu

More Information

Sponsor

Medtronic Vascular

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Medtronic Vascular on 2026-04-22.