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NCT06907147NARecruiting

SPYRAL GEMINI Pilot Study

Medtronic Vascular

Start Date

5/1/2025

Completion Date

12/22/2029

Summary

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.

Detailed Description

This study is exploratory in nature and will evaluate procedural and long-term safety of multi-organ denervation (MDN) and provide preliminary efficacy data in two parallel single arm cohorts: * Gemini Pilot Off Med: MDN for Hypertension Off Anti-hypertensive Meds and, * Gemini Pilot On Med: MDN for Hypertension and High Cardiovascular Risk On Anti-hypertensive Meds There is no pre-specified primary endpoint; however, the data will be used for hypothesis generation to be evaluated and confirmed in subsequent clinical investigation(s).

Eligibility Criteria

Age Range: 18 years to 80 years

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.

Interventions

DEVICE

Multi-Organ Denervation Gemini System

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Conditions

HypertensionVascular DiseasesCardiovascular DiseasesChronic Kidney DiseasesDiabetes Mellitus

Locations

Stanford Hospital and Clinics

Stanford, California 94305

United States

Orlando Health Heart & Vascular Institute

Orlando, Florida 32806

United States

BayCare Health System Mease Countryside Hospital

Safety Harbor, Florida 34695

United States

Piedmont Heart Institute

Atlanta, Georgia 30309-1281

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Henry Ford Providence Hospital

Southfield, Michigan 48075-4818

United States

North Mississippi Medical Center

Tupelo, Mississippi 38801-4934

United States

Renown Regional Medical Center

Reno, Nevada 89502

United States

Virtua Our Lady of Lourdes Hospital

Camden, New Jersey 08103

United States

University of North Carolina (UNC) Memorial Hospital

Chapel Hill, North Carolina 27599

United States

Baylor Heart & Vascular Hospital

Dallas, Texas 75226

United States

UT Health East Texas

Tyler, Texas 75701

United States

Royal Perth Hospital (Dobney Hypertension Centre)

Perth, 6000

Australia

University Hospital Erlangen

Erlangen, 91054

Germany

Universität des Saarlandes

Homburg, 66421

Germany

Hippokration General Hospital

Athens, 11527

Greece

University Hospital of Galway

Galway, H91 YR71

Ireland

University Hospital Basel

Basel, 4031

Switzerland