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Spyral InSight Study | Clinical Trials | Clareo Health

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RECRUITINGNANCT07013929

Spyral InSight Study

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.

Lead sponsor: Medtronic Vascular•2 locations•View source on ClinicalTrials.gov

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Contacts

Sjors Wijnands

CONTACT

+31 6 1113 5502 sjors.wijnands@medtronic.com

Marianne Wanten

CONTACT

+31 613703414 marianne.wanten@medtronic.com

Sponsors

Lead Sponsor

Medtronic Vascular

This study is exploratory in nature and an early-stage clinical assessment that will evaluate procedural and long-term safety of renal nerve stimulation (RNS) when performed prior to and post renal artery denervation (RDN) with the Symplicity Spyral system, with follow-up at 1, 3, 6 and 12 months. There is no pre-specified primary endpoint. However, the objectives of the Spyral InSight ECF study are as follows: * To assess safety of RNS when performed prior to and post RDN. * To characterize and quantify the physiological response to renal nerve stimulation in humans undergoing renal denervation per approved labeling.

Age

20 - 70 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•1. 20 - 70 years of age
•2. Office SBP ≥150 mmHg and \<180 mmHg and DBP ≥90 mmHg
•3. Individual is prescribed with one, two, or three antihypertensive medication classes
•4. 24-hour ABPM average of SBP ≥135 and \<170 mmHg at Baseline

Exclusion Criteria

•1. Prior renal denervation.
•2. Individual lacks appropriate renal artery Anatomy
•3. Has a renal artery stent
•4. Individual has an estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73m2
•5. Individual is taking SGLT2 inhibitors or GLP-1 agonists
•6. Individual requires chronic oxygen support or mechanical ventilation
•7. Primary pulmonary hypertension.
•8. Secondary cause of hypertension
•9. Pregnant, nursing or planning to become pregnant during the study.
•10. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
•11. Individual is currently taking anti-mineralocorticoid drugs.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 4, 2026Terms

Trial snapshot

StatusRECRUITING

PhaseNA

Enrollment19

Start dateJun 2025

Last updatedMay 4, 2026

Condition

Hypertension Vascular Diseases Cardiovascular Diseases

Locations shown

Hippokration General Hospital of Athens

Athens

University Hospital Galway

Galway

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 4, 2026Data synced to Clareo: June 27, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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