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HypertensionTHRIVENCT06559891

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

A study testing TIVUS™ Renal Denervation System in people with Hypertension, run by SoniVie Inc. at 51 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 22 to 75 years
Conditions the study is for
Hypertension
What is being tested?
TIVUS™ Renal Denervation System
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
261 participants
Where
51 sitesin 5 countries
Study dates
3 Oct 2024to 15 Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Appropriately signed and dated informed consent
  • Male and female adults with age between ≥22 and ≤75 years at time of consent
  • Documented history of hypertension
  • Previously or currently prescribed antihypertensive therapy
  • Subject has an office BP (average of 3 seated measurements) of:
  • 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,
Show all 13Show fewer
  • 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
  • Able and willing to comply with all study procedures
  • 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.

Who cannot join

  • 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
  • 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)
  • Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma HbA1c ≥ 9.0%)
  • eGFR of <40 mL/min/1.73 m2 CKD-EPI as calculated using the CKD-EPI 2021 equation
  • Cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) within 6 months prior to consent
  • 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
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  • Subject has severe valvular stenosis or insufficiency
  • 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
  • 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
  • Subject with rapid, uncontrolled, symptomatic atrial fibrillation
  • Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator)
  • Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
  • Subject has a planned major surgery (any procedure requiring general anesthesia) in the next 12 months.
  • Subject on anticoagulant therapy that cannot be temporarily withheld for study procedure.
  • Primary pulmonary hypertension
  • Documented contraindication or allergy to contrast medium not amenable to treatment
  • Limited life expectancy of < 1 year at the discretion of the Investigator
  • Night shift worker
  • 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.
  • Subject is taking immunosuppressive therapy for diseases featuring vasculitis
  • 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
  • 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
  • Subject has a planned major surgery or cardiovascular intervention in the next 6 months
  • Subject with history of renal transplantation
  • Evidence of active infection within 7 days of procedure (based on positive lab test and requiring therapy).
  • Subject has hypertrophic cardiomyopathy or amyloidosis.
  • Prior renal denervation procedure
  • Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional studies/registries is acceptable)
  • 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:
  • Main renal arteries lumen diameter < 4 mm.
  • Main renal treatable artery length <20mm (may include proximal branching).
  • Accessory renal arteries that supplies ≥ 25% of the parenchyma, and < 4 mm in lumen diameter.
  • Aorto-renal angle that prevents a safe cannulation of the renal artery.
  • 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.
  • 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).
  • Any renal artery stenosis > 30% by visual assessment.
  • Any renal artery aneurysm (>50% of the main renal artery reference vessel diameter by visual estimate).
  • Presence of fibromuscular dysplasia of the renal arteries
  • Significant renal artery atheroma, aneurysm, calcification in the target vessel identified on CT Angiogram

Trial locations and contacts

51 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Lisa Melchior contact

651-324-4931

lisa.melchior@bsci.com

Janelle Noble contact

612-598-4368

janelle.noble@bsci.com

51 sites in 5 countries

United States34 sites, 34 recruiting

  • Ascension St. John Clinical Research Institute

    Bartlesville, Oklahoma, 74006

    Anderson Mehrle, MD

    Recruiting

  • Cardiology, PC

    Birmingham, Alabama, 35211

    Susan DeRamus, SDeRamus@cardiologypc.com

    Farrell O Mendelsohn

    Recruiting

  • Connecticut Clinical Research, LLC (Bridgeport)

    Bridgeport, Connecticut, 06610

    Edward Tuohy, MD

    Recruiting

  • Virtua Health

    Camden, New Jersey, 08103

    Kintur Sanghvi, MD

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Herbert D Aronow, MD, haronow1@hfhs.org

    Michelle Butcher, Mbutcher1@hfhs.org

    Recruiting

  • Ascension Alexian Brothers

    Elk Grove Village, Illinois, 60007

    Alexander Fraley, M.D.

    Recruiting

  • Plaza Medical Center of Fort Worth

    Fort Worth, Texas, 76104

    Farhan Ali, M.D.

    Recruiting

  • Gulfport Memorial Hospital

    Gulfport, Mississippi, 39501

    Wayne Latack, MD

    Recruiting

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360

    Craig Walker, craig.walker@cardio.com

    Recruiting

  • Houston Medical Center

    Houston, Texas, 77004

    Arnav Kumar, M.D., Arnav.Kumar@hcahealthcare.com

    Recruiting

  • Jackson Heart Clinic

    Jackson, Mississippi, 39216

    J. Gray Bennett, MD

    Recruiting

  • St. Bernard's Medical Center

    Jonesboro, Arkansas, 72401

    Maximilliano Arroyo, MD, maxarr@hotmail.com

    Sasha Potter, mailto:sasha@cargresearch.com

    Recruiting

  • St Lukes Hospital

    Kansas City, Missouri, 64131

    Steven B Laster, MD, slaster@sait-lukes.org

    Recruiting

  • Lancaster General Health

    Lancaster, Pennsylvania, 17603

    Rupal Dumasia, MD

    Recruiting

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

    Andre Paixao, MD, Andre.Paixao@arheart.com

    Leybi Ramirez-Kelly, PhD, Leybi.Ramirez-Kelly@arheart.com

    Recruiting

  • St. Joseph

    Liverpool, New York, 13088

    Ayman Iskander, MD

    Recruiting

  • Cedar-Sinai Medical Center

    Los Angeles, California, 90048

    Florian Rader, M.D., Florian.Rader@cshs.org

    Maria Thottam, maria.thottam@cshs.org

    Recruiting

  • MUSC

    Mt. Pleasant, South Carolina, 29464

    Thomas Todoran, MD, MS

    Recruiting

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

    Matthew Saybolt, MD, matthew.saybolt@hmhn.org

    Recruiting

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

    James Jenkins, MD

    Recruiting

  • Nyph/Cumc

    New York, New York, 10032

    Ari Mintz, MD

    Recruiting

  • Stanford University

    Palo Alto, California, 94305

    David Lee, MD

    Recruiting

  • Ascension- Sacred Heart

    Pensacola, Florida, 32504

    Rohit Amin, MD, research-ash@ascension.org

    Recruiting

  • Penn Medicine

    Philadelphia, Pennsylvania, 19104

    Deborah Cohen, MD

    Recruiting

  • NC Heart and Vascular

    Raleigh, North Carolina, 27607

    James Pierre-Louis, Pierre-LouJames.Pierre-Louis@unchealth.unc.edu

    James Zidar

    Recruiting

  • Renown Regional Medical Center

    Reno, Nevada, 89502

    Michael Bloch, MD, michael.bloch@renown.org

    Recruiting

  • Chippenham Hospital

    Richmond, Virginia, 23225

    Nayef Abouzaki, MD, nabouzaki@vacardio.com

    Recruiting

  • Baycare Health System

    Safety Harbor, Florida, 34695

    Parag Patel, MD

    Recruiting

  • St Marks Hospital

    Salt Lake City, Utah, 37027

    Vamsee Yaganti, M.D., Vamsee.Yaganti@hcahealthcare.com

    Recruiting

  • HonorHealth

    Scottsdale, Arizona, 85258

    Taral Patel, MD, tapatel@honorhealth.com

    Recruiting

  • Henry Ford Providence Hospital

    Southfield, Michigan, 48075

    Shukri David, MD, shukri.david@asension.org

    Yulia Abidov, yabidov1@hfhs.org

    Recruiting

  • St. John's Prairie Heart

    Springfield, Illinois, 62710

    Avinash Murthy, MD

    Recruiting

  • Southern Illinois University, School of Medicine

    Springfield, Illinois, 62794

    John Flack, MD, jflack47@siumed.edu

    Recruiting

  • University of South Florida

    Tampa, Florida, 33606

    Fadi Matar, MD

    Recruiting

Other trials in United States

Germany9 sites, 9 recruiting

  • Dresden TUD University of Technology

    Dresden

    Axel Linke, MD, PhD

    Recruiting

  • Universitätsklinikum Erlangen

    Erlangen

    Roland Schmieder, MD, PhD

    Recruiting

  • Frankfurt Sankt Katharinen Krankenhaus

    Frankfurt

    Horst Sievert, MD

    Recruiting

  • Freiburg Herzzenrtum

    Freiburg im Breisgau

    Elias Noory, MD

    Recruiting

  • Marienkrankenhaus Hamburg

    Hamburg

    Jury Schewel, MD

    Recruiting

  • Herne Marien Hospital

    Herne

    Christian Ukena, MD, PhD

    Recruiting

  • Saarland University Hospital

    Homburg

    Kulenthiran Saarraaken, MD

    Recruiting

  • Herzzentrum Leipzig

    Leipzig

    Karl Fengler, MD

    Recruiting

  • Sana Kliniken Lubeck

    Lübeck

    Joachim Weil, MD

    Recruiting

Other trials in Germany

Greece3 sites, 3 recruiting

  • Athens Hippokration

    Athens

    K Tsioufis, MD, PhD

    Recruiting

  • University of Crete

    Heraklion

    Maria Marketou, MD, PhD

    Recruiting

  • Thessaloniki Hippokration General Hospital

    Thessaloniki

    Michalis Doumas, MD

    Recruiting

Other trials in Greece

Italy3 sites, 3 recruiting

  • Clinica Montevergine

    Mercogliano

    Luigi Salemme, MD

    Recruiting

  • Monza Policlinico

    Monza

    Filippo Scalise, MD

    Recruiting

  • Ospedale Sant'Andrea

    Roma

    Emanuele Barbato, MD, PhD

    Recruiting

Other trials in Italy

France2 sites, 2 recruiting

  • Hopital Saint André

    Bordeaux

    Antoine Cremer, MD

    Recruiting

  • Hôpital Européen Georges-Pompidou

    Paris

    Michel Azizi, MD, PhD

    Recruiting

Other trials in France

About this study

Official title: 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
Read the 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.

Conditions
Hypertension
Being tested
TIVUS™ Renal Denervation System, Sham
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TIVUS™ Renal Denervation SystemDevice

    Also called Renal Denervation

    Renal artery catheterization procedure used to denervate the renal sympathetic nerves in the perivascular space using ultrasound energy.

  • ShamOther

    For those subjects randomized to the sham control, the angiogram will serve as the sham procedure.

Study groups in NCT06559891
Study groupRoleWhat they receive
TIVUS™ Renal Denervation SystemExperimentalFollowing angiogram, subjects found anatomically eligible and randomized to the renal denervation arm will be treated with the TIVUS™ Renal Denervation System.
Receives: Device: TIVUS™ Renal Denervation System
ShamSham comparatorFor those subjects randomized to the sham control, the angiogram will serve as the sham procedure.
Receives: Other: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in average daytime ambulatory systolic BP

    Primary outcome

    Measured: From baseline to 2 months post-procedure

  2. Subject level composite of the incidence of Major Adverse Events (MAE)

    Safety outcome

    Measured: From Baseline to 30 day and 6 months post procedure

Secondary outcomes (10)

  1. Reduction in average 24-hr ambulatory systolic BP

    Secondary outcome

    Measured: From baseline to 2 Months post procedure

  2. Reduction in average home systolic BP

    Secondary outcome

    Measured: From baseline to 2 Months post procedure

  3. Reduction in average office systolic BP

    Secondary outcome

    Measured: From baseline to 2 Months post procedure

  4. Reduction in average daytime ambulatory diastolic BP

    Secondary outcome

    Measured: From baseline to 2 Months post procedure

  5. Reduction in average 24-hr ambulatory diastolic BP

    Secondary outcome

    Measured: From baseline to 2 Months post procedure

  6. Reduction in average home diastolic BP

    Secondary outcome

    Measured: From baseline to 2 Months post procedure

  7. Reduction in average office diastolic BP

    Secondary outcome

    Measured: From baseline to 2 Months post procedure

  8. Percentage of subjects with Systolic Blood Pressure (SBP) at target (daytime SBP <135 mmHg; office SBP <140

    Secondary outcome

    Measured: From baseline to 2 and 6 Months post procedure

  9. 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

    Secondary outcome

    Measured: From baseline to 2 and 6 Months post procedure

  10. Incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mm Hg

    Secondary outcome

    Measured: From baseline to 2, 6, and 12 Months post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2024
  2. Study start3 Oct 2024
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion15 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
2:1 randomization will be used to assign subjects to treatment (RDN) or control (sham). Randomization will occur immediately after the renal angiogram.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
261 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06559891
Sponsor's protocol ID
CLNS07-001
Acronym
THRIVE
Status last verified
Sep 2026
First submitted
24 Jul 2024
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TIVUS™ Renal Denervation System in people with Hypertension, run by SoniVie Inc. at 51 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Germany, Greece, Italy, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lisa Melchior (651-324-4931, lisa.melchior@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in average daytime ambulatory systolic BP (time frame: From baseline to 2 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06559891.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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