Spyral InSight Study
Recruiting · NCT07013929 · Interventional (participants receive a specific treatment) · Lead sponsor: Medtronic Vascular
View the official record on ClinicalTrials.gov →Interventions studied
Renal nerve stimulation
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.
Who can take part
Age range
20 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 20 - 70 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
- 24-hour ABPM average of SBP ≥135 and \<170 mmHg at Baseline
Exclusion criteria
- 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.
Where it is running
2 locations listed.
- Hippokration General Hospital of Athens - Athens, Greece
- University Hospital Galway - Galway, Ireland