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
Inclusion Criteria4
- years of age
- Office SBP ≥150 mmHg and \<180 mmHg and DBP ≥90 mmHg
- Individual is prescribed with one, two, or three antihypertensive medication classes
- hour ABPM average of SBP ≥135 and \<170 mmHg at Baseline
Exclusion Criteria11
- Prior renal denervation.
- Individual lacks appropriate renal artery Anatomy
- Has a renal artery stent
- Individual has an estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73m2
- Individual is taking SGLT2 inhibitors or GLP-1 agonists
- Individual requires chronic oxygen support or mechanical ventilation
- Primary pulmonary hypertension.
- Secondary cause of hypertension
- Pregnant, nursing or planning to become pregnant during the study.
- Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
- Individual is currently taking anti-mineralocorticoid drugs.
Interventions
DEVICERenal nerve stimulation
Renal nerve stimulation will be performed prior to and post renal denervation.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07013929
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