Gemini multi-organ denervation for uncontrolled high blood pressure

Global Pilot Study of rEnal and Hepatic coMbINed denervatIon in Subjects With Uncontrolled Hypertension With and Without High Cardiovascular Risk

The Gemini System is being tested to see if multi-organ denervation is safe and can lower blood pressure in adults with uncontrolled hypertension, with or without high cardiovascular risk.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 175 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Medtronic Vascular (Industry-sponsored)
• Locations: 13 sites (Stanford, California and 12 other locations)
• Trial ID: NCT06907147 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–80 with uncontrolled hypertension (office SBP 150–179 mmHg and 24‑hour ABPM SBP 140–169 mmHg), adequate renal and common hepatic artery anatomy, eGFR ≥40, and no recent major cardiovascular events are the intended candidates.

Not a fit: People with secondary hypertension, prior renal or hepatic denervation, recent NYHA class III/IV heart failure or recent stroke/TIA, type 1 diabetes or recent insulin use, unsuitable artery anatomy, or eGFR <40 are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the procedure could lower blood pressure and potentially reduce the need for medications in people with uncontrolled hypertension.

How similar studies have performed: Earlier renal denervation trials showed mixed results, with some later trials demonstrating blood pressure reductions in selected patients, while multi-organ denervation is a newer approach with limited prior evidence.

Eligibility criteria

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 this trial is running

Stanford, California and 12 other locations

• Stanford Hospital and Clinics — Stanford, California, 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)
• North Mississippi Medical Center — Tupelo, Mississippi, United States (Recruiting)
• Renown Regional Medical Center — Reno, Nevada, United States (Recruiting)
• Virtua Our Lady of Lourdes Hospital — Camden, New Jersey, United States (Recruiting)
• Baylor Heart & Vascular Hospital — Dallas, Texas, United States (Recruiting)
• UT Health East Texas — Tyler, Texas, United States (Recruiting)
• Royal Perth Hospital (Dobney Hypertension Centre) — Perth, Australia (Recruiting)
• Hippokration General Hospital — Athens, Greece (Recruiting)
• University Hospital of Galway — Galway, Ireland (Recruiting)
• University Hospital Basel — Basel, Switzerland (Recruiting)

Study contacts

• Study coordinator: Cecile Mahoney

Conditions Hypertension; Vascular Diseases; Cardiovascular Diseases; Chronic Kidney Diseases; Diabetes Mellitus; Renal Insufficiency; Chronic Disease; Disease Attributes