This is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System in subjects with uncontrolled stage 2 hypertension in order to assess the safety and effectiveness of the TIVUS™ System when used for renal artery denervation. The study will assess the acute and chronic safety of the procedure as well as the reduction in 24-hour ambulatory mean systolic blood pressure from baseline to 3 months after the procedure.
Nearly half of adults in the United States (108 million, or 45%) have hypertension defined as a systolic blood pressure ≥ 130 mm Hg or a diastolic blood pressure ≥ 80 mm Hg or are taking medication for hypertension. Hypertension is associated with cardiovascular and renal pathologies and leads to death if not treated appropriately. The cardiovascular risk factor doubles with each 20/10 mm Hg elevation in BP values above 115/75 mm Hg. The current first-line therapy for hypertension involves change in life-style (i.e., diet and exercise) and various medications. However, only about 1 in 4 treated adults (24%) with hypertension have their condition under control. Thus, they are at increased risk for the major side effects of chronically elevated blood pressure, myocardial infarction, stroke, renal disease and heart failure. High blood pressure was a primary or contributing cause of death for more than 494,873 people in the United States in 2018, and was estimated to affect around 1.13 billion people worldwide and resulted in approximately 10 million deaths worldwide, in 2015. About half of adults (45%) with uncontrolled hypertension have a blood pressure of 140/90 mm Hg or higher, now defined as Stage 2 hypertension. This includes 37 million U.S. adults. About 30 million adults are recommended to take medication. Almost two out of three of this group (19 million) have a blood pressure of 140/90 mm Hg or higher. The other 17 million adults are taking medications but are unable to lower their blood pressure below 140/90 mm Hg and are thus at increased risk for the risks associated with uncontrolled high blood pressure9. High blood pressure costs the United States about $131 billion each year, averaged over 12 years from 2003 to 2014. In the past decade, several devices were developed in order to target the autonomic nervous system and lower BP in patients with uncontrolled hypertension. These devices aim to provide additional treatment option for patients who do not respond to antihypertensive medication. These devices target other BP regulating mechanisms such as baroreflex activation, deep brain stimulation carotid body ablation, direct vagus nerve stimulation, cardiac neuromodulation, central iliac arteriovenous coupler as well as other devices are currently under research, however, there is no medical device that has been approved so far. The Therapeutic Intra Vascular UltraSound (TIVUS™) System is designed for renal artery nerve ablation using transluminal ultrasound (US). The TIVUS™ System is a high intensity, non-focused, ultrasound catheter system, which enables remote, localized, controlled, and repeatable thermal modulation of nerves adjacent to arterial vessel wall for performing safe and effective therapeutic artery sympathetic denervation. The ultrasonic energy is transmitted from a catheter positioned within the artery lumen, while avoiding direct contact with the artery wall.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
The TIVUS system will be used for renal denervation
Cardiology P.C.
Birmingham, Alabama, United States
ST Bernards Medical Center
Jonesboro, Arkansas, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Bridgeport Hospital
Incidence of Adverse Events
acute treatment related adverse events including including all-cause mortality, acute kidney injury, significant embolic event, renal artery perforation or dissection requiring intervention, vascular complications, stroke, myocardial infarction, or transient ischemic attack, deterioration in renal function end-stage renal failure, hospital admission for hypertensive crisis not related to confirmed nonadherence with medications or the protocol, new renal artery stenosis of more than 70% and major access site complications or cardiovascular complications
Time frame: from baseline to 1 month post procedure
Incidence of Adverse Events
chronic treatment related adverse events including including all-cause mortality, acute kidney injury, significant embolic event, renal artery perforation or dissection requiring intervention, vascular complications, stroke, myocardial infarction, or transient ischemic attack, deterioration in renal function end-stage renal failure, hospital admission for hypertensive crisis not related to confirmed nonadherence with medications or the protocol, new renal artery stenosis of more than 70% and major access site complications or cardiovascular complications
Time frame: from baseline to 12 month post procedure
Change in mean daytime ambulatory systolic BP
Reduction in daytime ambulatory mean systolic blood pressure from baseline to 3 months after the procedure.
Time frame: From baseline to 3 months post procedure
Change in mean 24-hr ambulatory systolic and diastolic bp
Reduction of 24-hour ambulatory mean systolic and diastolic blood pressure from baseline
Time frame: 3, 6, 12, 24, 36 months
Change in mean 24-hr ambulatory diastolic bp
Reduction of 24-hour ambulatory mean diastolic blood pressure from baseline
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Bridgeport, Connecticut, United States
Prairie Education and Research Cooperative
Springfield, Illinois, United States
Minneapolis Heart Institution Foundation
Minneapolis, Minnesota, United States
Columbia University/NYPH
New York, New York, United States
NC Heart and Vascular Research, LLC
Raleigh, North Carolina, United States
Medical University South Carolina
Charleston, South Carolina, United States
Time frame: 3 months
Change in mean daytime ambulatory systolic bp
Reduction of daylight ambulatory mean systolic blood pressure from baseline
Time frame: 6, 12, 24, 36 months
Change in mean nighttime ambulatory systolic and diastolic bp
Reduction of nighttime ambulatory mean systolic and diastolic blood pressure from baseline
Time frame: 3, 6, 12, 24, 36 months
Change in mean office systolic and diastolic BP
Reduction of office mean systolic and diastolic blood pressure from baseline
Time frame: 3, 6, 12, 24, 36 months
Change in mean 24-hr ambulatory pulse
Reduction in mean 24-hour ambulatory pulse pressure from baseline
Time frame: 3, 6, 12, 24, 36 months
Rate of patients achieving target 24-hr ambulatory mean systolic BP
Number of patients achieving target 24-hour ambulatory mean systolic blood pressure (\<130 mm Hg)
Time frame: 3, 6, 12, 24, 36 months
Rate of patients achieving target office systolic BP
Number of patients achieving target office systolic blood pressure (\<140 mm Hg)
Time frame: 3, 6, 12, 24, 36 months
Change in number of antihypertensive medications taken
Reduction in the number of antihypertensive medications taken and/or the dose taken
Time frame: 6, 12 months
Percentage of patients who respond to treatment
Percentage of patients who respond to the treatment, with response defined as a reduction of at least 10mm in mean 24-hour ambulatory systolic blood pressure
Time frame: 3, 6, 12 months
Incidence of hypertensive or hypotensive emergency episodes
Incidence of hypertensive or hypotensive emergency episodes resulting in hospitalization
Time frame: 3, 6, 12 months
Change in renal function based on laboratory parameters
Changes in renal function, based on laboratory parameters such as eGFR (CKD-EPI) and serum creatinine
Time frame: 3, 6, 12 months
Change in renal function based on artery stenosis
Changes in renal function, based on artery stenosis (\>70%)
Time frame: 6, 12 months
Incidence of heart failure
Episodes of heart failure events
Time frame: 3, 6, 12 months