Global Pilot Study of rEnal and Hepatic coMbINed denervatIon in Subjects With Uncontrolled Hypertension With and Without High Cardiovascular Risk
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of the SPYRAL GEMINI Pilot Study is to evaluate that multi-organ denervation with the Gemini System is safe and provide evidence of blood pressure reduction when studied in an uncontrolled hypertensive population with and without high cardiovascular risk.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
⁃ All Subjects (both cohorts):
• ≥18 and ≤80 years of age.
• Diagnosed with HTN and has a baseline office SBP ≥150 mmHg and \<180 mmHg and an office DBP ≥ 90 mmHg.
• 24-hour average SBP ≥140 mmHg and \<170 mmHg measured by ABPM at Baseline.
Locations
United States
Georgia
Piedmont Heart Institute
RECRUITING
Atlanta
Michigan
Henry Ford Providence Hospital
RECRUITING
Southfield
Mississippi
North Mississippi Medical Center
RECRUITING
Tupelo
New Jersey
Virtua Our Lady of Lourdes Hospital
RECRUITING
Camden
Nevada
Renown Regional Medical Center
RECRUITING
Reno
Texas
Baylor Heart & Vascular Hospital
RECRUITING
Dallas
Other Locations
Australia
Royal Perth Hospital (Dobney Hypertension Centre)
RECRUITING
Perth
Greece
Hippokration General Hospital
RECRUITING
Athens
Contact Information
Primary
Cecile Mahoney
Cecile.C.Mahoney@medtronic.com
+17635051057
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2029-12-22
Participants
Target number of participants: 175
Treatments
Experimental: Gemini Pilot Off Med: Multi-Organ Denervation for Hypertension Off Anti-hypertensive Meds
Experimental: Gemini Pilot On Med: MDN for Hypertension and High Cardiovascular Risk On Anti-hypertensive Meds.
Related Therapeutic Areas
Sponsors
Leads: Medtronic Vascular