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SPYRAL GEMINI Pilot Study

Description

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.

Conditions

HypertensionVascular DiseasesCardiovascular DiseasesChronic Kidney DiseasesDiabetes Mellitus
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Related Conditions:

HypertensionVascular DiseasesCardiovascular DiseasesChronic Kidney DiseasesDiabetes Mellitus

Study Overview

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Study Details

Study overview

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.

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

SPYRAL GEMINI Pilot Study

Condition
Hypertension
Intervention / Treatment

-

Contacts and Locations

Atlanta

Piedmont Heart Institute, Atlanta, Georgia, United States, 30309-1281

Southfield

Henry Ford Providence Hospital, Southfield, Michigan, United States, 48075-4818

Tupelo

North Mississippi Medical Center, Tupelo, Mississippi, United States, 38801-4934

Dallas

Baylor Heart & Vascular Hospital, Dallas, Texas, United States, 75226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.
  • 1. Individual lacks appropriate renal artery OR common hepatic artery anatomy.
  • 2. Prior renal or hepatic denervation.
  • 3. Prior stroke or transient ischemic attack (TIA).
  • 4. Documented Type 1 diabetes or use of insulin or sulfonylureas within 6 months.
  • 5. Secondary cause of hypertension.
  • 6. Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement.
  • 7. Estimated glomerular filtration rate (eGFR) of \<40
  • 8. Pregnant, nursing or planning to become pregnant during the study.
  • 9. Primary pulmonary arterial hypertension.
  • 10. History or evidence of active / suspected chronic liver or biliary disease.
  • 11. Current or chronic pancreatitis.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medtronic Vascular,

Study Record Dates

2029-12-22