RECRUITING

SPYRAL GEMINI Pilot Study

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Conditions

HypertensionVascular DiseasesCardiovascular DiseasesChronic Kidney DiseasesDiabetes MellitusRenal InsufficiencyChronic DiseaseDisease AttributesPathologic ProcessesKidney DiseasesDenervationRenal DenervationHepatic Denervation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-05-01
Study Completion:2029-12-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06907147

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. ≥18 and ≤80 years of age.
  2. 2. Diagnosed with HTN and has a baseline office SBP ≥150 mmHg and \<180 mmHg and an office DBP ≥ 90 mmHg.
  3. 3. 24-hour average SBP ≥140 mmHg and \<170 mmHg measured by ABPM at Baseline.
  1. 1. Individual lacks appropriate renal artery OR common hepatic artery anatomy.
  2. 2. Prior renal or hepatic denervation.
  3. 3. Prior stroke or transient ischemic attack (TIA).
  4. 4. Documented Type 1 diabetes or use of insulin or sulfonylureas within 6 months.
  5. 5. Secondary cause of hypertension.
  6. 6. Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement.
  7. 7. Estimated glomerular filtration rate (eGFR) of \<40
  8. 8. Pregnant, nursing or planning to become pregnant during the study.
  9. 9. Primary pulmonary arterial hypertension.
  10. 10. History or evidence of active / suspected chronic liver or biliary disease.
  11. 11. Current or chronic pancreatitis.

Contacts and Locations

Study Contact

Cecile Mahoney
CONTACT
+17635051057
Cecile.C.Mahoney@medtronic.com

Study Locations (Sites)

Piedmont Heart Institute
Atlanta, Georgia, 30309-1281
United States
Henry Ford Providence Hospital
Southfield, Michigan, 48075-4818
United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801-4934
United States
Baylor Heart & Vascular Hospital
Dallas, Texas, 75226
United States

Collaborators and Investigators

Sponsor: Medtronic Vascular

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-01
Study Completion Date2029-12-22

Study Record Updates

Study Start Date2025-05-01
Study Completion Date2029-12-22

Terms related to this study

Keywords Provided by Researchers

  • Renal Insufficiency
  • Chronic Disease
  • Disease Attributes
  • Pathologic Processes
  • Kidney Diseases
  • Hypertension
  • Cardiovascular Diseases
  • Vascular Diseases
  • Denervation
  • Renal Denervation
  • Hepatic Denervation

Additional Relevant MeSH Terms

  • Hypertension
  • Vascular Diseases
  • Cardiovascular Diseases
  • Chronic Kidney Diseases
  • Diabetes Mellitus