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New ultrasound treatment for high blood pressure

A Pivotal, Prospective, Multicenter, 2:1 Randomized, Double Blind, Controlled, Study Comparing the THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension (The THRIVE Study)

Not applicable Interventional SoniVie Inc. · NCT06559891

This study is testing a new ultrasound treatment for high blood pressure in patients who will stop their usual medications for a short time to see if it helps them manage their condition better.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment261 (estimated)
Ages22 Years to 75 Years
SexAll
SponsorSoniVie Inc. Industry-sponsored
Locations50 sites (Birmingham, Alabama and 49 other locations)
Trial IDNCT06559891 on ClinicalTrials.gov

What this trial studies

The THRIVE study aims to evaluate the effectiveness and safety of the TIVUS system for treating hypertension in patients who will temporarily stop their antihypertensive medications. This international, multicenter, randomized, double-blind, sham-controlled trial will involve participants undergoing a 4-week wash-out period before the procedure and a 2-month follow-up without medications. Patients with uncontrolled hypertension will be monitored for up to 36 months post-procedure, with the option to cross-over to the TIVUS treatment if initially assigned to the sham group. The study seeks to provide insights into a novel approach to managing hypertension.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 to 75 with a documented history of hypertension who are willing to stop their antihypertensive medications for the study duration.

Not a fit: Patients with hypertension that is not responsive to any form of treatment or those who cannot stop their medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new, effective option for patients struggling to control their hypertension.

How similar studies have performed: While the TIVUS approach is relatively novel, similar studies in renal denervation have shown promise in managing hypertension.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Appropriately signed and dated informed consent
2. Male and female adults with age between ≥22 and ≤75 years at time of consent
3. Documented history of hypertension
4. Previously or currently prescribed antihypertensive therapy
5. Subject has an office BP (average of 3 seated measurements) of:

   1. Uncontrolled BP: ≥ 140/90 mmHg \<180/110 mmHg at Screening Visit (V0) while stable for at least 4 weeks on 0-2 anti-hypertensive medications of different classes\* and willing to stop anti-hypertensive medication(s) for 4 weeks wash-out and 2-months post-procedure, (subjects with a history of treatment with anti-hypertensive medications but are not currently taking any at screening will undergo a 4-week run-in period) or,
   2. Controlled BP: \< 140/90 mmHg while stable for at least 4 weeks on 1-2 antihypertensive medications of different classes and willing to stop anti-hypertensive medication(s) for 4 weeks wash-out and 2-months post-procedure
6. Able and willing to comply with all study procedures
7. Subject is willing to have and is a good candidate for conscious sedation

Subjects who meet the following criteria will be considered eligible for randomization:

* Documented daytime systolic ABP ≥ 135 mmHg and \< 180 mmHg after 4-week washout/run-in period.\*\*
* Suitable renal anatomy compatible with the renal denervation procedure, documented by renal CTA or MRA of good quality performed within one year prior to consent (a CTA or MRA will be obtained in subjects without a recent (≤1 year) cross-sectional renal imaging). The renal angiogram procedure done in the cath lab prior to randomization will serve as the final anatomy compatibility check.

  * Potassium-sparing diuretics such as Amiloride hydrochloride and Triamterene may be prescribed in combination with another diuretic (e.g. a thiazide or loop diuretic) for their potassium conservation properties. In this situation, the diuretic combination is considered as a single class of anti-hypertensive.

Exclusion Criteria:

1. 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
2. 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)
3. Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma HbA1c ≥ 9.0%)
4. eGFR of \<40 mL/min/1.73 m2 CKD-EPI as calculated using the CKD-EPI 2021 equation
5. Cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) within 6 months prior to consent
6. 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
7. Subject has severe valvular stenosis or insufficiency
8. 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
9. 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
10. Subject with rapid, uncontrolled, symptomatic atrial fibrillation
11. Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator)
12. Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
13. Subject has a planned major surgery (any procedure requiring general anesthesia) in the next 12 months.
14. Subject on anticoagulant therapy that cannot be temporarily withheld for study procedure.
15. Primary pulmonary hypertension
16. Documented contraindication or allergy to contrast medium not amenable to treatment
17. Limited life expectancy of \< 1 year at the discretion of the Investigator
18. Night shift worker
19. 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.
20. Subject is taking immunosuppressive therapy for diseases featuring vasculitis
21. 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
22. 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
23. Subject has a planned major surgery or cardiovascular intervention in the next 6 months
24. Subject with history of renal transplantation
25. Evidence of active infection within 7 days of procedure (based on positive lab test and requiring therapy).
26. Subject has hypertrophic cardiomyopathy or amyloidosis.
27. Prior renal denervation procedure
28. Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional studies/registries is acceptable)
29. Subject on a beta blocker for a condition other than antihypertension

Angiographic Exclusion Criteria:

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:

1. Main renal arteries lumen diameter \< 4 mm.
2. Main renal treatable artery length \<20mm (may include proximal branching).
3. Accessory renal arteries that supplies ≥ 25% of the parenchyma, and \< 4 mm in lumen diameter.
4. Aorto-renal angle that prevents a safe cannulation of the renal artery.
5. 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.
6. 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).
7. Any renal artery stenosis \> 30% by visual assessment.
8. Any renal artery aneurysm (\>50% of the main renal artery reference vessel diameter by visual estimate).
9. Presence of fibromuscular dysplasia of the renal arteries
10. Significant renal artery atheroma, aneurysm, calcification in the target vessel identified on CT Angiogram

Where this trial is running

Birmingham, Alabama and 49 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hypertension
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.