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SPYRAL GEMINI Pilot Study

Recruiting

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

Who can join

Ages 18 to 80 · All sexes

Full 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.

About the 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.

What is being tested

Sponsor: Medtronic Vascular · Participants: 175 · Started: May 1, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06907147

Locations in the U.S.

CaliforniaStanford Hospital and Clinics, Stanford
FloridaOrlando Health Heart & Vascular Institute, Orlando
BayCare Health System Mease Countryside Hospital, Safety Harbor
GeorgiaPiedmont Heart Institute, Atlanta
MassachusettsBeth Israel Deaconess Medical Center, Boston
MichiganHenry Ford Providence Hospital, Southfield
MississippiNorth Mississippi Medical Center, Tupelo
NevadaRenown Regional Medical Center, Reno
New JerseyVirtua Our Lady of Lourdes Hospital, Camden
North CarolinaUniversity of North Carolina (UNC) Memorial Hospital, Chapel Hill
TexasBaylor Heart & Vascular Hospital, Dallas
UT Health East Texas, Tyler

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.