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

May 21, 2026 updated by: SoniVie Inc.

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)

The primary objective of the THRIVE Pivotal study is to demonstrate the adjunctive effectiveness and the safety of the TIVUS system in:

  1. subjects with uncontrolled hypertension (HTN) receiving 0 - 2 anti-hypertensive drugs of different classes in whom the anti-hypertensive medications will be stopped for a 4-week wash-out period before RDN/Sham procedure and during 2 months after procedure.
  2. subjects with controlled hypertension receiving 1 - 2 anti-hypertensive drugs of different classes and who accept to be off-medications for a 4-week wash-out period before RDN/Sham procedure and 2 months after the procedure

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

THRIVE is an international, multicenter, randomized, double blind, sham-controlled study, designed to demonstrate the adjunctive effectiveness and safety of the TIVUS System in hypertensive subjects while subjects are maintained off-antihypertensive medications for a 4-week wash-out period before RDN/Sham procedure and 2 months after procedure. At two months after procedure, subjects with uncontrolled hypertension are put back on antihypertensive medication according to a medication escalation protocol. Unblinding will be performed at 6 months. Uncontrolled sham subjects can cross-over to RDN procedure at 6-months. The sham procedure will be minimally invasive to reduce risk to subjects. All subjects treated with TIVUS will be followed for a maximum of 36 months post procedure.

Study Type

Interventional

Enrollment (Estimated)

261

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France
        • Recruiting
        • Hopital Saint André
        • Contact:
          • Antoine Cremer, MD
      • Paris, France
        • Recruiting
        • Hôpital Européen Georges-Pompidou
        • Contact:
          • Michel Azizi, MD, PhD
  • Germany
      • Dresden, Germany
        • Recruiting
        • Dresden TUD University of Technology
        • Contact:
          • Axel Linke, MD, PhD
      • Erlangen, Germany
        • Recruiting
        • Universitätsklinikum Erlangen
        • Contact:
          • Roland Schmieder, MD, PhD
      • Frankfurt, Germany
        • Recruiting
        • Frankfurt Sankt Katharinen Krankenhaus
        • Contact:
          • Horst Sievert, MD
      • Freiburg im Breisgau, Germany
        • Recruiting
        • Freiburg Herzzenrtum
        • Contact:
          • Elias Noory, MD
      • Hamburg, Germany
        • Recruiting
        • Marienkrankenhaus Hamburg
        • Contact:
          • Jury Schewel, MD
      • Herne, Germany
        • Recruiting
        • Herne Marien Hospital
        • Contact:
          • Christian Ukena, MD, PhD
      • Homburg, Germany
        • Recruiting
        • Saarland University Hospital
        • Contact:
          • Kulenthiran Saarraaken, MD
      • Leipzig, Germany
        • Recruiting
        • Herzzentrum Leipzig
        • Contact:
          • Karl Fengler, MD
      • Lübeck, Germany
        • Recruiting
        • Sana Kliniken Lubeck
        • Contact:
          • Joachim Weil, MD
  • Greece
      • Athens, Greece
        • Recruiting
        • Athens Hippokration
        • Contact:
          • K Tsioufis, MD, PhD
      • Heraklion, Greece
        • Recruiting
        • University of Crete
        • Contact:
          • Maria Marketou, MD, PhD
      • Thessaloniki, Greece
        • Recruiting
        • Thessaloniki Hippokration General Hospital
        • Contact:
          • Michalis Doumas, MD
  • Italy
      • Mercogliano, Italy
        • Recruiting
        • Clinica Montevergine
        • Contact:
          • Luigi Salemme, MD
      • Monza, Italy
        • Recruiting
        • Monza Policlinico
        • Contact:
          • Filippo Scalise, MD
      • Roma, Italy
        • Recruiting
        • Ospedale Sant'Andrea
        • Contact:
          • Emanuele Barbato, MD, PhD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Recruiting
        • Cardiology, PC
        • Contact:
        • Principal Investigator:
          • Farrell O Mendelsohn
    • Arizona
      • Scottsdale, Arizona, United States, 85258
    • Arkansas
    • California
      • Los Angeles, California, United States, 90048
      • Palo Alto, California, United States, 94305
        • Recruiting
        • Stanford University
        • Contact:
          • David Lee, MD
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Recruiting
        • Bridgeport
        • Contact:
          • Edward Touhy, MD
    • Florida
      • Pensecola, Florida, United States, 32504
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida
        • Contact:
          • Fadi Matar, MD
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Recruiting
        • Ascension Alexian Brothers
        • Principal Investigator:
          • Alexander Fraley, M.D.
      • Springfield, Illinois, United States, 62794
        • Recruiting
        • Southern Illinois University, School of Medicine
        • Contact:
      • Springfield, Illinois, United States, 62710
        • Recruiting
        • St. John's Prairie Heart
        • Contact:
          • Avinash Murthy, MD
    • Louisiana
      • Houma, Louisiana, United States, 70360
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Medical Center
        • Contact:
          • James Jenkins, MD
    • Michigan
    • Mississippi
      • Gulfport, Mississippi, United States, 39501
        • Recruiting
        • Gulfport Memorial Hospital
        • Contact:
          • Wayne Latack, MD
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • Jackson Heart
        • Contact:
          • Grey Bennett, MD
    • Missouri
      • Kansas City, Missouri, United States, 64131
    • Nevada
      • Reno, Nevada, United States, 89502
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Virtua Health
        • Contact:
          • Kintur Sanghvi, MD
      • Neptune City, New Jersey, United States, 07753
    • New York
      • Liverpool, New York, United States, 13088
        • Recruiting
        • St. Joseph
        • Contact:
          • Ayman Iskander, MD
      • New York, New York, United States, 10032
        • Recruiting
        • Nyph/Cumc
        • Contact:
          • Ari Mintz, MD
    • North Carolina
    • Oklahoma
      • Bartlesville, Oklahoma, United States, 74006
        • Recruiting
        • Ascension St. John Clinical Research Institute
        • Contact:
          • Anderson Mehrle, MD
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17603
        • Recruiting
        • Lancaster General Health
        • Contact:
          • Rupal Dumasia, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Penn Medicine
        • Contact:
          • Deborah Cohen, MD
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Recruiting
        • MUSC
        • Contact:
          • Thomas Todoran, MD, MS
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Medical City
        • Contact:
          • Ali Farhan, M.D.
      • Houston, Texas, United States, 77004
    • Utah
    • Virginia
      • Richmond, Virginia, United States, 23225

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TIVUS™ Renal Denervation System
Following angiogram, subjects found anatomically eligible and randomized to the renal denervation arm will be treated with the TIVUS™ Renal Denervation System.
Device: TIVUS™ Renal Denervation System
Renal artery catheterization procedure used to denervate the renal sympathetic nerves in the perivascular space using ultrasound energy.
Other Names:
  • Renal Denervation
Sham Comparator: Sham
For those subjects randomized to the sham control, the angiogram will serve as the sham procedure.
Other: Sham
For those subjects randomized to the sham control, the angiogram will serve as the sham procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in average daytime ambulatory systolic BP
Time Frame: From baseline to 2 months post-procedure
Primary outcome
From baseline to 2 months post-procedure
Subject level composite of the incidence of Major Adverse Events (MAE)
Time Frame: From Baseline to 30 day and 6 months post procedure
Safety outcome
From Baseline to 30 day and 6 months post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in average 24-hr ambulatory systolic BP
Time Frame: From baseline to 2 Months post procedure
Secondary outcome
From baseline to 2 Months post procedure
Reduction in average home systolic BP
Time Frame: From baseline to 2 Months post procedure
Secondary outcome
From baseline to 2 Months post procedure
Reduction in average office systolic BP
Time Frame: From baseline to 2 Months post procedure
Secondary outcome
From baseline to 2 Months post procedure
Reduction in average daytime ambulatory diastolic BP
Time Frame: From baseline to 2 Months post procedure
Secondary outcome
From baseline to 2 Months post procedure
Reduction in average 24-hr ambulatory diastolic BP
Time Frame: From baseline to 2 Months post procedure
Secondary outcome
From baseline to 2 Months post procedure
Reduction in average home diastolic BP
Time Frame: From baseline to 2 Months post procedure
Secondary outcome
From baseline to 2 Months post procedure
Reduction in average office diastolic BP
Time Frame: From baseline to 2 Months post procedure
Secondary outcome
From baseline to 2 Months post procedure
Percentage of subjects with Systolic Blood Pressure (SBP) at target (daytime SBP <135 mmHg; office SBP <140
Time Frame: From baseline to 2 and 6 Months post procedure
Secondary outcome
From baseline to 2 and 6 Months post procedure
Percentage of subjects with SBP at target (daytime SBP <135 mmHg; office SBP <140 mmHg) in the absence of. changes in hypertensive medication in each arm
Time Frame: From baseline to 2 and 6 Months post procedure
Secondary outcome
From baseline to 2 and 6 Months post procedure
Incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mm Hg
Time Frame: From baseline to 2, 6, and 12 Months post procedure
Secondary outcome
From baseline to 2, 6, and 12 Months post procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in average night-time ambulatory systolic/diastolic BP
Time Frame: From baseline to 2, 6 and 12, Months post procedure
Observational outcome
From baseline to 2, 6 and 12, Months post procedure
Reduction in average daytime & 24-hr ambulatory systolic BP at 6- and 12-months post procedure.
Time Frame: From baseline to 6 and 12 Months post procedure
Observational outcome
From baseline to 6 and 12 Months post procedure
Reduction in average daytime & 24-hr ambulatory diastolic BP
Time Frame: From baseline to 6 and 12 Months post procedure
Observational outcome
From baseline to 6 and 12 Months post procedure
Reduction in average office systolic BP
Time Frame: From baseline to 6 and 12 Months post procedure
Observational outcome
From baseline to 6 and 12 Months post procedure
Reduction in average home systolic/diastolic BP
Time Frame: From baseline to 1, 3, 4, 5, 6, and 12-Months post procedure
Observational outcome
From baseline to 1, 3, 4, 5, 6, and 12-Months post procedure
Reduction in office and ambulatory pulse pressure
Time Frame: From baseline to 2, 6 and 12 Months post procedure
Observational outcome
From baseline to 2, 6 and 12 Months post procedure
Reduction in office and ambulatory heart rate
Time Frame: From baseline to 2, 6, and 12 Months post procedure
Observational outcome
From baseline to 2, 6, and 12 Months post procedure
Antihypertensive medication burden (number of antihypertensive drugs, doses, classes)
Time Frame: From baseline to 2, 6 and 12 Months post procedure
Observational outcome
From baseline to 2, 6 and 12 Months post procedure
Percentage of subjects meeting escape criteria
Time Frame: From baseline to 2 Months post procedure
Observational outcome
From baseline to 2 Months post procedure
Percentage of subjects requiring initiation of antihypertensive drug therapy
Time Frame: From baseline to 2 and 6 Months post procedure
Observational outcome
From baseline to 2 and 6 Months post procedure
Percentage of subjects without any antihypertensive treatment
Time Frame: From baseline to 6 and 12 Months post procedure
Observational outcome
From baseline to 6 and 12 Months post procedure
Percentage of subjects requiring initiation of anti-hypertensive drug therapy at any available time points post procedure
Time Frame: From baseline through completion of study
Observational outcome
From baseline through completion of study
Change in adherence to medications assessed by urine chemical adherence testing using liquid chromatography with tandem mass spectrometry (LCMSMS)
Time Frame: From baseline to 2, 6, 12, 24 and 36 Months.
Observational outcome
From baseline to 2, 6, 12, 24 and 36 Months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SoniVie Inc.

Collaborators

European Cardiovascular Research Center
NAMSA
IQVIA Pty Ltd

Investigators

  • Study Chair: Ajay Kirtane, MD, Columbia University
  • Study Chair: Michel Azizi, MD, George Pompidou Hospital
  • Study Chair: Felix Mahfoud, MD, University of Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

August 15, 2028

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

August 15, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLNS07-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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