THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension
NCT ID: NCT06559891
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
261 participants
INTERVENTIONAL
2024-10-03
2028-08-15
Brief Summary
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1. subjects with hypertension (HTN) receiving up to 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 up to 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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
ABPM measurements will be sent to an independent core lab for data cleaning and analysis and will be blinded to the randomization assignment.
Study Groups
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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.
TIVUS™ Renal Denervation System
Renal artery catheterization procedure used to denervate the renal sympathetic nerves in the perivascular space using ultrasound energy.
Sham
For those subjects randomized to the sham control, the angiogram will serve as the sham procedure.
Sham
For those subjects randomized to the sham control, the angiogram will serve as the sham procedure.
Interventions
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TIVUS™ Renal Denervation System
Renal artery catheterization procedure used to denervate the renal sympathetic nerves in the perivascular space using ultrasound energy.
Sham
For those subjects randomized to the sham control, the angiogram will serve as the sham procedure.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
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
22 Years
75 Years
ALL
No
Sponsors
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NAMSA
OTHER
European Cardiovascular Research Center
NETWORK
SoniVie Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ajay Kirtane, MD
Role: STUDY_CHAIR
Columbia University
Michel Azizi, MD
Role: STUDY_CHAIR
George Pompidou Hospital
Felix Mahfoud, MD
Role: STUDY_CHAIR
University of Basel
Locations
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Cardiology, PC
Birmingham, Alabama, United States
Honor Health Research Institue
Scottsdale, Arizona, United States
St. Bernard's Medical Center
Jonesboro, Arkansas, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Cedar-Sinai Medical Center
Los Angeles, California, United States
Stanford University
Stanford, California, United States
Bridgeport
Bridgeport, Connecticut, United States
University of South Florida
Tampa, Florida, United States
Ascension Alexian Brothers
Elk Grove Village, Illinois, United States
St. John's Prairie Heart
Springfield, Illinois, United States
Southern Illinois University, School of Medicine
Springfield, Illinois, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Gulfport Memorial Hospital
Gulfport, Mississippi, United States
Jackson Heart
Jackson, Mississippi, United States
St. Luke's Hospital
Kansas City, Missouri, United States
Renown Regional Medical Center
Reno, Nevada, United States
Virtua Health
Camden, New Jersey, United States
Nyph/Cumc
New York, New York, United States
NC Heart and Vascular
Raleigh, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical City
Fort Worth, Texas, United States
Houston Medical Center
Houston, Texas, United States
St Marks Hospital
Salt Lake City, Utah, United States
Chippenham Hospital
Richmond, Virginia, United States
Hopital Saint André
Bordeaux, , France
Hôpital Européen Georges-Pompidou
Paris, , France
Universitätsklinikum Erlangen
Erlangen, , Germany
Frankfurt Sankt Katharinen Krankenhaus
Frankfurt, , Germany
Freiburg Herzzenrtum
Freiburg im Breisgau, , Germany
Marienkrankenhaus Hamburg
Hamburg, , Germany
Herne Marien Hospital
Herne, , Germany
Herzzentrum Leipzig
Leipzig, , Germany
Sana Kliniken Lubeck
Lübeck, , Germany
Athens Hippokration
Athens, , Greece
University of Crete
Heraklion, , Greece
Thessaloniki Hippokration General Hospital
Thessaloniki, , Greece
Clinica Montevergine
Mercogliano, , Italy
Ospedale Sant'Andrea
Roma, , Italy
Countries
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Central Contacts
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Facility Contacts
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Susan DeRamus
Role: primary
Taral Patel, MD
Role: primary
Maximilliano Arroyo, MD
Role: primary
Sasha Potter
Role: backup
Andre Paixao, MD
Role: primary
Leybi Ramirez-Kelly, PhD
Role: backup
Florian Radar, M.D.
Role: primary
Maria Thottam
Role: backup
David Lee, MD
Role: primary
Florian Rader, MD
Role: primary
Fadi Mater, MD
Role: primary
Avinash Murthy, MD
Role: primary
John Flack, MD
Role: primary
Craig Walker
Role: primary
James Jenkins, MD
Role: primary
Wayne Latack, MD
Role: primary
Grey Bennett, MD
Role: primary
Steven Laster, MD
Role: primary
Michael Bloch, MD
Role: primary
Kintur Sanghvi, MD
Role: primary
Ajay Kirtane, MD
Role: primary
Suzanne Edwards, PhD
Role: backup
James Pierre-Louis
Role: primary
Deborah Cohen, MD
Role: primary
Farhan Ali, M.D.
Role: primary
Arnav Kumar, M.D.
Role: primary
Vamsee Yaganti, M.D.
Role: primary
Nayef Abouzaki, MD
Role: primary
Antoine Cremer, MD
Role: primary
Michel Azizi, MD, PhD
Role: primary
Roland Schmieder, MD, PhD
Role: primary
Horst Sievert, MD
Role: primary
Elias Noory, MD
Role: primary
Jury Schewel, MD
Role: primary
Christian Ukena, MD, PhD
Role: primary
Karl Fengler, MD
Role: primary
Joachim Weil, MD
Role: primary
K Tsioufis, MD, PhD
Role: primary
Maria Marketou, MD, PhD
Role: primary
Michalis Doumas, MD
Role: primary
Luigi Salemme, MD
Role: primary
Emanuele Barbato, MD, PhD
Role: primary
Other Identifiers
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CLNS07-001
Identifier Type: -
Identifier Source: org_study_id