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SPYRAL GEMINI Pilot Study

Medtronic Vascular · NCT06907147

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
175
US sites recruiting
12
Study start
May 1, 2025
Record last updated
October 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Multi-Organ Denervation Gemini System

Conditions: Hypertension; Vascular Diseases; Cardiovascular Diseases; Chronic Kidney Diseases; Diabetes Mellitus

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

All Subjects (both cohorts):

  • ≥18 and ≤80 years of age.
  • Diagnosed with HTN and has a baseline office SBP ≥150 mmHg and \<180 mmHg and an office DBP ≥ 90 mmHg.
  • 24-hour average SBP ≥140 mmHg and \<170 mmHg measured by ABPM at Baseline.

Exclusion Criteria

  • Individual lacks appropriate renal artery OR common hepatic artery anatomy.
  • Prior renal or hepatic denervation.
  • History of NYHA Class III or IV heart failure within 6 months of screening visit.
  • Stroke or transient ischemic attack (TIA) within 6 months of screening visit or any history of stroke leading to permanent disability.
  • Documented Type 1 diabetes or use of insulin within 6 months.
  • Secondary cause of hypertension.
  • Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement.
  • Estimated glomerular filtration rate (eGFR) of \<40
  • Pregnant, nursing or planning to become pregnant during the study.
  • Primary pulmonary arterial hypertension.
  • History or evidence of active / suspected chronic liver or biliary disease.
  • Current or chronic pancreatitis.

Recruiting US locations

  • Stanford Hospital and Clinics

    Stanford, CA 94305

    Site contact: Maria Perlas · 650-723-2094 · mperlas@stanford.edu

  • Orlando Health Heart & Vascular Institute

    Orlando, FL 32806

    Site contact: Farhan J. Khawaja, MD · 321-841-6444 · farhan.khawaja@orlandohealth.com

  • BayCare Health System Mease Countryside Hospital

    Safety Harbor, FL 34695

    Site contact: Kristy Roakes · 727-724-8611 · kristy.roakes@baycare.org

  • Piedmont Heart Institute

    Atlanta, GA 30309-1281

    Site contact: David Kandzari, MD · 404-605-2800 · david.kandzari@piedmont.org

  • Beth Israel Deaconess Medical Center

    Boston, MA 02215

    Site contact: Jenifer Kaufman, DNP · 617-632-8956 · jmkaufma@bidmc.harvard.edu

  • Henry Ford Providence Hospital

    Southfield, MI 48075-4818

    Site contact: Yulia Abidov · 248-849-5328 · yabidov1@hfhs.org

  • North Mississippi Medical Center

    Tupelo, MS 38801-4934

    Site contact: Brittany Cook · 662-620-6853 · brittany.cook@nmhs.net

  • Renown Regional Medical Center

    Reno, NV 89502

    Site contact: Kristen Gurnea, MPH · kristen.gurnea@renown.org

  • Virtua Our Lady of Lourdes Hospital

    Camden, NJ 08103

    Site contact: Kristin Broderick, BS · 609-969-1175 · kbroderick@virtua.org

  • University of North Carolina (UNC) Memorial Hospital

    Chapel Hill, NC 27599

    Site contact: George Stouffer, MD · 984-974-7244 · rick_stouffer@med.unc.edu

  • Baylor Heart & Vascular Hospital

    Dallas, TX 75226

    Site contact: Merielle H. Boatman, MBA · 214-820-2273 · merielle.boatman@bswhealth.org

  • UT Health East Texas

    Tyler, TX 75701

    Site contact: Elizabeth Seal, BSc, CCRC · 903-510-7291 · elizabeth.seal@uthet.com

Study contacts (from the official record)

  • Cecile Mahoney · +17635051057 · Cecile.C.Mahoney@medtronic.com
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SPYRAL GEMINI Pilot Study (NCT06907147) | Bored Studies