THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension

Exclusion Criteria40

• 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
• Cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) within 6 months prior to consent
• History of severe cardiovascular event (e.g. myocardial infarction, unstable angina, CABG, acute heart failure requiring hospitalization (NYHA III-IV) within 12 months prior to consent
• Subject has severe valvular stenosis or insufficiency
• Documented repeat (\>1) hospitalization for hypertensive crisis within the prior 12 months and/or any hospitalization for hypertensive crisis within three (3) months prior to consent
• Prescribed to any standard antihypertensive cardiovascular medication (e.g. beta blockers) for other chronic conditions (e.g. ischemic heart disease) such that discontinuation might pose serious risk to health in the opinion of the investigator
• Subject with rapid, uncontrolled, symptomatic atrial fibrillation
• Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator)
• Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
• Subject has a planned major surgery (any procedure requiring general anesthesia) in the next 12 months.
• Subject on anticoagulant therapy that cannot be temporarily withheld for study procedure.
• Primary pulmonary hypertension
• Documented contraindication or allergy to contrast medium not amenable to treatment
• Limited life expectancy of \< 1 year at the discretion of the Investigator
• Night shift worker
• Subject has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment.
• Subject is taking immunosuppressive therapy for diseases featuring vasculitis
• Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders
• Pregnant, nursing or planning to become pregnant within 12 months post procedure.
• Negative pregnancy test required, documented within a maximum of 7 days prior to procedure for all women of childbearing potential. Documentation of effective contraception is also required for women of childbearing potential
• Subject has a planned major surgery or cardiovascular intervention in the next 6 months
• Subject with history of renal transplantation
• Evidence of active infection within 7 days of procedure (based on positive lab test and requiring therapy).
• Subject has hypertrophic cardiomyopathy or amyloidosis.
• Prior renal denervation procedure
• Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional studies/registries is acceptable)
• Subject on a beta blocker for a condition other than antihypertension
• The following characteristics identified either on the renal artery CT scan or MRI or on the Eligibility II Renal artery Angiogram will prevent the subject from being included:
• Main renal arteries lumen diameter \< 4 mm.
• Main renal treatable artery length \<20mm (may include proximal branching).
• Accessory renal arteries that supplies ≥ 25% of the parenchyma, and \< 4 mm in lumen diameter.
• Aorto-renal angle that prevents a safe cannulation of the renal artery.
• Severe common femoral artery, common and/or external iliac artery, renal, iliac or aortic calcification or tortuosity that may compromise the safe performance and completion of the TIVUS™ procedure.
• Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, would interfere with safe cannulation of the renal artery or meets local standards for surgical repair or interventional dilation (NOTE: vessel areas with calcification and fibromuscular dysplasia (FMD) should be avoided as intended treatment areas).
• Any renal artery stenosis \> 30% by visual assessment.
• Any renal artery aneurysm (\>50% of the main renal artery reference vessel diameter by visual estimate).
• Presence of fibromuscular dysplasia of the renal arteries
• Significant renal artery atheroma, aneurysm, calcification in the target vessel identified on CT Angiogram