The primary objective of the THRIVE Pivotal study is to demonstrate the adjunctive effectiveness and the safety of the TIVUS system in:
1. subjects with uncontrolled hypertension (HTN) receiving 0 - 2 anti-hypertensive drugs of different classes in whom the anti-hypertensive medications will be stopped for a 4-week wash-out period before RDN/Sham procedure and during 2 months after procedure. 2. subjects with controlled hypertension receiving 1 - 2 anti-hypertensive drugs of different classes and who accept to be off-medications for a 4-week wash-out period before RDN/Sham procedure and 2 months after the procedure
Appropriately signed and dated informed consent
Male and female adults with age between ≥22 and ≤75 years at time of consent
Documented history of hypertension
Previously or currently prescribed antihypertensive therapy
Subject has been previously diagnosed with abnormal renal artery anatomy and/or renal anatomy such as a single kidney, ectopic or horseshoe kidney, polycystic kidney disease, kidney tumors or other findings precluding renal denervation therapy as detailed in the angiographic exclusion criteria
Uncorrected causes of secondary hypertension other than sleep apnea (including, but not limited to): aldosteronism, renal parenchymal disease, renovascular disease, excess catecholamines, Cushing's syndrome, erythropoietin use, pheochromocytoma, hypo/hyperthyroidism, hyperparathyroidism, acromegaly)
Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma HbA1c ≥ 9.0%)
eGFR of <40 mL/min/1.73 m2 CKD-EPI as calculated using the CKD-EPI 2021 equation
Crossover
TIVUS™ Renal Denervation System
DeviceRenal artery catheterization procedure used to denervate the renal sympathetic nerves in the perivascular space using ultrasound energy.
Sham
Other interventionFor those subjects randomized to the sham control, the angiogram will serve as the sham procedure.
Reduction in average daytime ambulatory systolic BP
Primary outcome
Subject level composite of the incidence of Major Adverse Events (MAE)
Safety outcome
Reduction in average 24-hr ambulatory systolic BP
Secondary outcome
Reduction in average home systolic BP
Secondary outcome
Reduction in average office systolic BP
Secondary outcome
Reduction in average daytime ambulatory diastolic BP
Secondary outcome
Reduction in average night-time ambulatory systolic/diastolic BP
Observational outcome
Reduction in average daytime & 24-hr ambulatory systolic BP at 6- and 12-months post procedure.
Observational outcome
Reduction in average daytime & 24-hr ambulatory diastolic BP
Observational outcome
Reduction in average office systolic BP
Observational outcome
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SoniVie Inc.
Lead sponsor
NAMSA
Collaborator
European Cardiovascular Research Center
Collaborator
IQVIA Pty Ltd
Collaborator