RecruitingNot ApplicableNCT07013929

Spyral InSight Study

Spyral InSight Early Clinical Feasibility Study


Sponsor

Medtronic Vascular

Enrollment

19 participants

Start Date

Jun 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 20 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a minimally invasive procedure called renal denervation — where nerves around the kidney arteries are treated to help lower blood pressure — in people whose high blood pressure is not well controlled with medication alone. **You may be eligible if...** - You are between 20 and 70 years old - You have high blood pressure (systolic 150–180 mmHg and diastolic at or above 90 mmHg) in the doctor's office - You are currently taking one, two, or three blood pressure medications - Your 24-hour blood pressure monitoring confirms elevated readings **You may NOT be eligible if...** - You have previously had a renal denervation procedure - You have a stent in your kidney artery or unsuitable kidney artery anatomy - Your kidney function is significantly reduced - You are taking SGLT2 inhibitors or GLP-1 receptor agonists (certain diabetes drugs) - You are pregnant, nursing, or planning to become pregnant - You have pulmonary hypertension or a secondary cause of high blood pressure - You are currently taking anti-mineralocorticoid medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERenal nerve stimulation

Renal nerve stimulation will be performed prior to and post renal denervation.


Locations(2)

Hippokration General Hospital of Athens

Athens, Greece

University Hospital Galway

Galway, Ireland

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NCT07013929


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