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

NCT05372679 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CLNS05-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Uncontrolled Stage 2 Hypertension

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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.

  From baseline to 3 months post procedure

Secondary Outcomes (14)

• Change in mean 24-hr ambulatory systolic and diastolic bp

  3, 6, 12, 24, 36 months

• Change in mean 24-hr ambulatory diastolic bp

  3 months

• Change in mean daytime ambulatory systolic bp

  6, 12, 24, 36 months

• Change in mean nighttime ambulatory systolic and diastolic bp

  3, 6, 12, 24, 36 months

• Change in mean office systolic and diastolic BP

  3, 6, 12, 24, 36 months

Study Arms (1)

Renal denervation

EXPERIMENTAL

Denervating the sympathetic nerves surrounding the renal vasculature using unfocused ultrasound

Device: Renal denervation

Interventions

Renal denervation DEVICE

The TIVUS system will be used for renal denervation

Renal denervation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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.

Sponsors & Collaborators

• SoniVie Inc.: lead

Study Sites (9)

Cardiology P.C.

Birmingham, Alabama, 35211, United States

Location

ST Bernards Medical Center

Jonesboro, Arkansas, 72401, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Prairie Education and Research Cooperative

Springfield, Illinois, 62701, United States

Location

Minneapolis Heart Institution Foundation

Minneapolis, Minnesota, 55407, United States

Location

Columbia University/NYPH

New York, New York, 10032, United States

Location

NC Heart and Vascular Research, LLC

Raleigh, North Carolina, 27607, United States

Location

Medical University South Carolina

Charleston, South Carolina, 29425, United States

Location

Study Officials

• Ajay Kirtane, MD

  Columbia University/NYPH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, non-randomized, open-label clinical study

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 13, 2022
• Study Start: November 11, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)