RecruitingHypertensionVascular DiseasesCardiovascular Diseases

SPYRAL GEMINI Pilot Study

Eligible age

18–80 yrs

Accepts

All genders

Locations

10 states

Healthy volunteers

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About this study

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.

Sponsor: Medtronic Vascular

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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