Gemini multi-organ denervation for uncontrolled high blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an exploratory, single-arm pilot with two parallel cohorts: one cohort off antihypertensive medications and one cohort on medications with high cardiovascular risk. Participants undergo multi-organ denervation using the Gemini System and will be followed for procedural and long-term safety and preliminary blood pressure effects. There is no pre-specified primary endpoint; the data are intended to generate hypotheses for later studies. Entry requires elevated office and 24-hour ambulatory blood pressure measurements and adequate renal and hepatic artery anatomy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Stanford Hospital and Clinics
  Stanford, California, United States Recruiting
• Orlando Health Heart & Vascular Institute
  Orlando, Florida, United States Recruiting
• BayCare Health System Mease Countryside Hospital
  Safety Harbor, Florida, United States Recruiting
• Piedmont Heart Institute
  Atlanta, Georgia, United States Recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• Henry Ford Providence Hospital
  Southfield, Michigan, United States Recruiting

Study contacts

• Study coordinator: Cecile Mahoney
• Email: Cecile.C.Mahoney@medtronic.com
• Phone: +17635051057

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.