Spyral InSight Early Clinical Feasibility Study
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Ireland
University Hospital Galway
RECRUITING
Galway
Contact Information
Primary
Sjors Wijnands
sjors.wijnands@medtronic.com
+31 6 1113 5502
Backup
Marianne Wanten
marianne.wanten@medtronic.com
+31 613703414
Time Frame
Start Date: 2025-06-09
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 19
Treatments
Experimental: Renal nerve stimulation performed prior to and post renal artery denervation (RDN)
Related Therapeutic Areas
Sponsors
Leads: Medtronic Vascular