REDUCED 1 - Renal Denervation Using Ultrasonic Catheter EmitteD Energy Study /

Running, not enrolling · Not applicable

Conditions studied: Uncontrolled Stage 2 Hypertension

In brief

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.

Key facts

Study ID

NCT05372679

Run by

SoniVie Inc.

People needed

25

Starts

2022-11-11

Expected to finish

2027-12-01

Last updated by the study team

2026-05-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent to participate in the study obtained from the patient, according to local regulations, prior to initiation of any study mandated procedure.
• Male or female, ≥ 18 years of age and ≤ 80 years of age at the time of screening.
• Individual has office systolic blood pressure (SBP) ≥ 140 mm Hg but < 180 mm Hg, and a diastolic blood pressure (DBP) ≥ 90 mm Hg but < 110 mm Hg based on an average of 3 office seated blood pressure readings measured by a manual, automated or semi-automated validated BP monitor, on current medications. 4. Documented mean daytime ABPM systolic blood pressure (SBP) ≥ 135 mm Hg but < 180 mm Hg, after a 4 week stabilization period.
• Patient is either on at least one anti-hypertensive medication at maximal tolerated dose with a medically documented intolerance to one or more medications, or on three medications where one is a diuretic.
• Patient is willing and expected to maintain their anti-hypertensive medication regimen for at least 3 months.
• Patient is able and willing to comply with all study procedures.

You may not qualify if…

• Patient has been previously diagnosed with abnormal renal artery anatomy and/or renal anatomy such as single kidney, other renal development anomaly such as ectopic or horseshoe kidney, or polycystic kidney disease precluding renal denervation therapy as detailed in the angiographic exclusion criteria.
• Pregnant or breastfeeding women or women planning a pregnancy within 12 months of study enrollment.
• Patient has an estimated glomerular filtration rate (eGFR) of < 40mL/min/1.73m2 CKD-EPI as calculated using the CKD-EPI 2021 equation.
• Patients with uncontrolled rapid AF.
• Patient has had a previous renal denervation procedure.
• Patients with daytime ABPM mean systolic blood pressure (SBP) > 180 mm Hg.
• Patient has Type 1 diabetes or poorly controlled Type 2 diabetes (HbA1c > 9%).
• Patients with history of myocardial infarction, unstable angina pectoris, heart failure, cerebrovascular accident, or widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
• Patient has a planned major surgery or cardiovascular intervention in the next 6 months.
• Patient who has undergone a major surgery or cardiovascular intervention in the previous 3 months.
• Patient 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.
• Patient is taking immunosuppressive therapy for diseases featuring vasculitis.
• Patient on anticoagulant therapy that cannot be temporarily withheld for study procedure.
• Contraindication to recommended denervation procedure medications or intravascular contrast that cannot be adequately controlled with pre-medication.
• Concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints. For patient previously participating in a drug trial, allow a wash-off period of at least 5 half-lives of the investigational drug.
• Patient with significant co-morbid condition(s) which, at the discretion of the PI, are deemed to prohibit study entry.
• Patient works the night shift.
• Patient has valvular stenosis with risk of cardiac event with significant and/or abrupt decline in systolic blood pressure.
• Untreated secondary cause of hypertension.
• Device therapy within the past five years for the treatment of hypertension.
• Prior renal stent or angioplasty.
• Life expectancy <1 year.
• Patients with history of renal transplant or planned renal transplantation within the next year.
• History of one or more episodes of severe orthostatic hypotension within the past year.
• Patient has unstable cardiac or pulmonary disease (including pulmonary hypertension) requiring chronic oxygen support.

Where it is running

• 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 — 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

Full record on ClinicalTrials.gov

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