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.
≥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.
Individual lacks appropriate renal artery OR common hepatic artery anatomy.
Prior renal or hepatic denervation.
History of NYHA Class III or IV heart failure within 6 months of screening visit.
Stroke or transient ischemic attack (TIA) within 6 months of screening visit or any history of stroke leading to permanent disability.
Parallel
Multi-Organ Denervation Gemini System
DeviceAfter angiography according to standard procedures, subjects are treated with renal denervation followed by hepatic denervation.
Change in office blood pressure
Change in 24-hour ambulatory blood pressure
Change in blood pressure from baseline as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) at 3-and 6-months post-procedure
Change in daytime blood pressure
Change in daytime blood pressure from baseline as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) at 3- and 6-months post-procedure
Change in nighttime blood pressure
Change in nighttime blood pressure from baseline as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) at 3- and 6-months post-procedure
Change in office blood pressure
Change in office blood pressure from baseline at 1-, 3-, 6-, 12-, 24- and 36-months post-procedure
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