Actively Recruiting

Phase Not Applicable
Age: 20Years - 70Years
All Genders
NCT07013929

Spyral InSight Study

Led by Medtronic Vascular · Updated on 2026-05-04

19

Participants Needed

2

Research Sites

107 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of the Spyral InSight Early Clinical Feasibility Study is to characterize the physiological response to renal nerve stimulation (RNS) in humans prior to and post renal denervation.

CONDITIONS

Official Title

Spyral InSight Study

Who Can Participate

Age: 20Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 20 to 70 years of age
  • Office systolic blood pressure (SBP) between 150 and less than 180 mmHg and diastolic blood pressure (DBP) of at least 90 mmHg
  • Currently prescribed one, two, or three classes of antihypertensive medications
  • 24-hour ambulatory blood pressure monitoring (ABPM) average SBP between 135 and less than 170 mmHg at baseline
Not Eligible

You will not qualify if you...

  • Prior renal denervation procedure
  • Inappropriate renal artery anatomy
  • Presence of a renal artery stent
  • Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73m2
  • Currently taking SGLT2 inhibitors or GLP-1 agonists
  • Requires chronic oxygen support or mechanical ventilation
  • Diagnosed with primary pulmonary hypertension
  • Secondary causes of hypertension
  • Pregnant, nursing, or planning pregnancy during the study
  • Conditions preventing accurate blood pressure measurement
  • Currently taking anti-mineralocorticoid medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Hippokration General Hospital of Athens

Athens, Greece, 11527

Actively Recruiting

2

University Hospital Galway

Galway, Ireland, H91 YR71

Actively Recruiting

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Research Team

S

Sjors Wijnands

CONTACT

M

Marianne Wanten

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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