SPYRAL GEMINI Pilot Study
Start Date
5/1/2025
Completion Date
12/22/2029
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.
Detailed Description
This study is exploratory in nature and will evaluate procedural and long-term safety of multi-organ denervation (MDN) and provide preliminary efficacy data in two parallel single arm cohorts: * Gemini Pilot Off Med: MDN for Hypertension Off Anti-hypertensive Meds and, * Gemini Pilot On Med: MDN for Hypertension and High Cardiovascular Risk On Anti-hypertensive Meds There is no pre-specified primary endpoint; however, the data will be used for hypothesis generation to be evaluated and confirmed in subsequent clinical investigation(s).
Eligibility Criteria
Age Range: 18 years to 80 years
Interventions
Multi-Organ Denervation Gemini System
Conditions
Locations
Stanford Hospital and Clinics
Stanford, California 94305
United States
Orlando Health Heart & Vascular Institute
Orlando, Florida 32806
United States
BayCare Health System Mease Countryside Hospital
Safety Harbor, Florida 34695
United States
Piedmont Heart Institute
Atlanta, Georgia 30309-1281
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Henry Ford Providence Hospital
Southfield, Michigan 48075-4818
United States
North Mississippi Medical Center
Tupelo, Mississippi 38801-4934
United States
Renown Regional Medical Center
Reno, Nevada 89502
United States
Virtua Our Lady of Lourdes Hospital
Camden, New Jersey 08103
United States
University of North Carolina (UNC) Memorial Hospital
Chapel Hill, North Carolina 27599
United States
Baylor Heart & Vascular Hospital
Dallas, Texas 75226
United States
UT Health East Texas
Tyler, Texas 75701
United States
Royal Perth Hospital (Dobney Hypertension Centre)
Perth, 6000
Australia
University Hospital Erlangen
Erlangen, 91054
Germany
Universität des Saarlandes
Homburg, 66421
Germany
Hippokration General Hospital
Athens, 11527
Greece
University Hospital of Galway
Galway, H91 YR71
Ireland
University Hospital Basel
Basel, 4031
Switzerland