Phase
Condition
Diabetes And Hypertension
Kidney Disease
Kidney Failure
Treatment
Multi-Organ Denervation Gemini System
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 anoffice DBP ≥ 90 mmHg.
24-hour average SBP ≥140 mmHg and <170 mmHg measured by ABPM at Baseline.
Exclusion
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 anyhistory 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 anaccurate 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.
Study Design
Study Description
Connect with a study center
Dobney Hypertension Centre
Perth, 6000
AustraliaActive - Recruiting
Royal Perth Hospital (Dobney Hypertension Centre)
Perth, 6000
AustraliaActive - Recruiting
Royal Perth Hospital (Dobney Hypertension Centre)
Perth 2063523, 6000
AustraliaSite Not Available
Universität des Saarlandes
Homburg, 66421
GermanyActive - Recruiting
Hippokration General Hospital
Athens, 11527
GreeceActive - Recruiting
Hippokration General Hospital
Athens 264371, 11527
GreeceSite Not Available
University Hospital of Galway
Galway, H91 YR71
IrelandActive - Recruiting
University Hospital of Galway
Galway 2964180, H91 YR71
IrelandSite Not Available
University Hospital Basel
Basel, 4031
SwitzerlandActive - Recruiting
University Hospital Basel
Basel 2661604, 4031
SwitzerlandSite Not Available
Stanford Hospital and Clinics
Stanford, California 94305
United StatesActive - Recruiting
Stanford Hospital and Clinics
Stanford 5398563, California 5332921 94305
United StatesSite Not Available
Orlando Health Heart & Vascular Institute
Orlando, Florida 32806
United StatesActive - Recruiting
BayCare Health System Mease Countryside Hospital
Safety Harbor, Florida 34695
United StatesActive - Recruiting
Piedmont Heart Institute
Atlanta, Georgia 30309-1281
United StatesActive - Recruiting
Piedmont Heart Institute
Atlanta 4180439, Georgia 4197000 30309-1281
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesActive - Recruiting
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
United StatesSite Not Available
Henry Ford Providence Hospital
Southfield, Michigan 48075-4818
United StatesActive - Recruiting
Henry Ford Providence Hospital
Southfield 5010636, Michigan 5001836 48075-4818
United StatesSite Not Available
North Mississippi Medical Center
Tupelo, Mississippi 38801-4934
United StatesActive - Recruiting
North Mississippi Medical Center
Tupelo 4448903, Mississippi 4436296 38801-4934
United StatesSite Not Available
Renown Regional Medical Center
Reno, Nevada 89502
United StatesActive - Recruiting
Renown Regional Medical Center
Reno 5511077, Nevada 5509151 89502
United StatesSite Not Available
Virtua Our Lady of Lourdes Hospital
Camden, New Jersey 08103
United StatesActive - Recruiting
Virtua Our Lady of Lourdes Hospital
Camden 4501018, New Jersey 5101760 08103
United StatesSite Not Available
Baylor Heart & Vascular Hospital
Dallas, Texas 75226
United StatesActive - Recruiting
UT Health East Texas
Tyler, Texas 75701
United StatesActive - Recruiting
Baylor Heart & Vascular Hospital
Dallas 4684888, Texas 4736286 75226
United StatesSite Not Available
UT Health East Texas
Tyler 4738214, Texas 4736286 75701
United StatesSite Not Available

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