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SPYRAL GEMINI Pilot Study

NCT06907147 · Medtronic Vascular
In plain English

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Official title
Global Pilot Study of rEnal and Hepatic coMbINed denervatIon in Subjects With Uncontrolled Hypertension With and Without High Cardiovascular Risk
About this study
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
Inclusion Criteria: All Subjects (both cohorts): 1. ≥18 and ≤80 years of age. 2. Diagnosed with HTN and has a baseline office SBP ≥150 mmHg and \<180 mmHg and an office DBP ≥ 90 mmHg. 3. 24-hour average SBP ≥140 mmHg and \<170 mmHg measured by ABPM at Baseline. Exclusion Criteria: 1. Individual lacks appropriate renal artery OR common hepatic artery anatomy. 2. Prior renal or hepatic denervation. 3. History of NYHA Class III or IV heart failure within 6 months of screening visit. 4. Stroke or transient ischemic attack (TIA) within 6 months of screening visit or any history of stroke leading to permanent disability. 5. Documented Type 1 diabetes or use of insulin within 6 months. 6. Secondary cause of hypertension. 7. Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement. 8. Estimated glomerular filtration rate (eGFR) of \<40 9. Pregnant, nursing or planning to become pregnant during the study. 10. Primary pulmonary arterial hypertension. 11. History or evidence of active / suspected chronic liver or biliary disease. 12. Current or chronic pancreatitis.
Study design
Enrollment target: 175 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-05-01
Estimated completion: 2029-12-22
Last updated: 2026-04-14
Interventions
Device: Multi-Organ Denervation Gemini System
Primary outcomes
  • Change in office blood pressure (From baseline to 36 months post-procedure)
Sponsor
Medtronic Vascular · industry
Contacts & investigators
ContactCecile Mahoney · contact · Cecile.C.Mahoney@medtronic.com · +17635051057
All locations (13)
Stanford Hospital and ClinicsRecruiting
Stanford, California, United States
Piedmont Heart InstituteRecruiting
Atlanta, Georgia, United States
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
Henry Ford Providence HospitalRecruiting
Southfield, Michigan, United States
North Mississippi Medical CenterRecruiting
Tupelo, Mississippi, United States
Renown Regional Medical CenterRecruiting
Reno, Nevada, United States
Virtua Our Lady of Lourdes HospitalRecruiting
Camden, New Jersey, United States
Baylor Heart & Vascular HospitalRecruiting
Dallas, Texas, United States
UT Health East TexasRecruiting
Tyler, Texas, United States
Royal Perth Hospital (Dobney Hypertension Centre)Recruiting
Perth, Australia
Hippokration General HospitalRecruiting
Athens, Greece
University Hospital of GalwayRecruiting
Galway, Ireland
University Hospital BaselRecruiting
Basel, Switzerland
SPYRAL GEMINI Pilot Study · TrialPath