The TIVUS II is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System consisting of three (3) concurrent cohorts: * TIVUS™ Severe Resistant HTN Cohort * TIVUS™ Moderate Resistant HTN Cohort * TIVUS™ Failed RF Therapy Cohort
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Royal Perth Hospital
Perth, Australia
Change in office Systolic Blood Pressure (SBP) from baseline to 6-month
Time frame: 6 month
Procedural complications
Time frame: 30 day
Major Adverse Events (MAE)
Time frame: 1 year
Preservation of renal function
Time frame: 1 year
Cardiovascular complications
Time frame: 1 year
Blood pressure reduction
Time frame: 1 year
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