Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
175 participants
INTERVENTIONAL
2025-05-01
2029-12-22
Brief Summary
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Detailed Description
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* 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).
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Gemini Pilot Off Med: Multi-Organ Denervation for Hypertension Off Anti-hypertensive Meds
Multi-Organ Denervation Gemini System
After angiography according to standard procedures, subjects are treated with renal denervation followed by hepatic denervation.
Gemini Pilot On Med: MDN for Hypertension and High Cardiovascular Risk On Anti-hypertensive Meds.
Multi-Organ Denervation Gemini System
After angiography according to standard procedures, subjects are treated with renal denervation followed by hepatic denervation.
Interventions
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Multi-Organ Denervation Gemini System
After angiography according to standard procedures, subjects are treated with renal denervation followed by hepatic denervation.
Eligibility Criteria
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Inclusion Criteria
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
2. Prior renal or hepatic denervation.
3. Prior stroke or transient ischemic attack (TIA).
4. Documented Type 1 diabetes or use of insulin or sulfonylureas within 6 months.
5. Secondary cause of hypertension.
6. Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement.
7. Estimated glomerular filtration rate (eGFR) of \<40
8. Pregnant, nursing or planning to become pregnant during the study.
9. Primary pulmonary arterial hypertension.
10. History or evidence of active / suspected chronic liver or biliary disease.
11. Current or chronic pancreatitis.
18 Years
80 Years
ALL
No
Sponsors
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Medtronic Vascular
INDUSTRY
Responsible Party
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Locations
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Piedmont Heart Institute
Atlanta, Georgia, United States
Henry Ford Providence Hospital
Southfield, Michigan, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
Renown Regional Medical Center
Reno, Nevada, United States
Virtua Our Lady of Lourdes Hospital
Camden, New Jersey, United States
Baylor Heart & Vascular Hospital
Dallas, Texas, United States
Royal Perth Hospital (Dobney Hypertension Centre)
Perth, , Australia
Hippokration General Hospital
Athens, , Greece
University Hospital Basel
Basel, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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David Kandzari, MD
Role: primary
Wendy Noland
Role: backup
Yulia Abidov
Role: primary
Brittany Cook
Role: primary
Kristen Gurnea, MPH
Role: primary
Lisa English, BS
Role: backup
Kristin Broderick, BS
Role: primary
Merielle H. Boatman, MBA
Role: primary
Markus Schlaich, MD
Role: primary
Anu Joyson
Role: backup
Konstantinos Tsioufis, MD
Role: primary
Lucas Lauder, MD
Role: primary
Other Identifiers
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MDT23034
Identifier Type: -
Identifier Source: org_study_id