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โ† Trials
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SPYRAL GEMINI Pilot Study

RecruitingNAAges 18 Years - 80 YearsAllMedtronic Vascular
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: All Subjects (both cohorts): 1. โ‰ฅ18 and โ‰ค80 years of age. 2. Diagnosed with HTN and has a baseline office SBP โ‰ฅ150 mmHg and \<180 mmHg and an office DBP โ‰ฅ 90 mmHg. 3. 24-hour average SBP โ‰ฅ140 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.
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What it tests

  • Multi-Organ Denervation Gemini System
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Where

18 sites
Stanford Hospital and Clinics
Stanford, United States
Orlando Health Heart & Vascular Institute
Orlando, United States
BayCare Health System Mease Countryside Hospital
Safety Harbor, United States
Piedmont Heart Institute
Atlanta, United States
Beth Israel Deaconess Medical Center
Boston, United States
Henry Ford Providence Hospital
Southfield, United States
North Mississippi Medical Center
Tupelo, United States
Renown Regional Medical Center
Reno, United States

โ€ฆand 10 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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