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

NCT06559891 | Recruiting DMC FDA Device

• 1 other identifier: CLNS07-001
• Study Type: interventional
• Target: 261
• Locations: 5 countries
• Sites: 50

Brief Summary

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

1. 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. 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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Reduction in average daytime ambulatory systolic BP

  Primary outcome

  From baseline to 2 months post-procedure

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

  Safety outcome

  From Baseline to 30 day and 6 months post procedure

Secondary Outcomes (10)

• Reduction in average 24-hr ambulatory systolic BP

  From baseline to 2 Months post procedure

• Reduction in average home systolic BP

  From baseline to 2 Months post procedure

• Reduction in average office systolic BP

  From baseline to 2 Months post procedure

• Reduction in average daytime ambulatory diastolic BP

  From baseline to 2 Months post procedure

• Reduction in average 24-hr ambulatory diastolic BP

  From baseline to 2 Months post procedure

Other Outcomes (13)

• Reduction in average night-time ambulatory systolic/diastolic BP

  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.

  From baseline to 6 and 12 Months post procedure

• Reduction in average daytime & 24-hr ambulatory diastolic BP

  From baseline to 6 and 12 Months post procedure

Study Arms (2)

TIVUS™ Renal Denervation System

EXPERIMENTAL

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

Sham

SHAM COMPARATOR

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

Other: Sham

Interventions

Sham OTHER

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

Sham

TIVUS™ Renal Denervation System DEVICE

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

Also known as: Renal Denervation

TIVUS™ Renal Denervation System

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• IQVIA Pty Ltd: collaborator
• European Cardiovascular Research Center: collaborator
• SoniVie Inc.: lead
• NAMSA: collaborator

Study Sites (50)

Cardiology, PC

Birmingham, Alabama, 35211, United States

RECRUITING

Honor Health Research Institue

Scottsdale, Arizona, 85258, United States

RECRUITING

St. Bernard's Medical Center

Jonesboro, Arkansas, 72401, United States

RECRUITING

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

RECRUITING

Cedar-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Stanford University

Palo Alto, California, 94305, United States

RECRUITING

Bridgeport

Bridgeport, Connecticut, 06610, United States

RECRUITING

Ascension- Sacred Heart

Pensecola, Florida, 32504, United States

RECRUITING

University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

Ascension Alexian Brothers

Elk Grove Village, Illinois, 60007, United States

RECRUITING

St. John's Prairie Heart

Springfield, Illinois, 62710, United States

RECRUITING

Southern Illinois University, School of Medicine

Springfield, Illinois, 62794, United States

RECRUITING

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

RECRUITING

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Henry Ford Providence Hospital

Southfield, Michigan, 48075, United States

RECRUITING

Gulfport Memorial Hospital

Gulfport, Mississippi, 39501, United States

RECRUITING

Jackson Heart

Jackson, Mississippi, 39216, United States

RECRUITING

St Lukes Hospital

Kansas City, Missouri, 64131, United States

RECRUITING

Renown Regional Medical Center

Reno, Nevada, 89502, United States

RECRUITING

Virtua Health

Camden, New Jersey, 08103, United States

RECRUITING

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

RECRUITING

St. Joseph

Liverpool, New York, 13088, United States

RECRUITING

Nyph/Cumc

New York, New York, 10032, United States

RECRUITING

NC Heart and Vascular

Raleigh, North Carolina, 27607, United States

RECRUITING

Ascension St. John Clinical Research Institute

Bartlesville, Oklahoma, 74006, United States

RECRUITING

Lancaster General Health

Lancaster, Pennsylvania, 17603, United States

RECRUITING

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MUSC

Mt. Pleasant, South Carolina, 29464, United States

RECRUITING

Medical City

Fort Worth, Texas, 76104, United States

RECRUITING

Houston Medical Center

Houston, Texas, 77004, United States

RECRUITING

St Marks Hospital

Salt Lake City, Utah, 37027, United States

RECRUITING

Chippenham Hospital

Richmond, Virginia, 23225, United States

RECRUITING

Hopital Saint André

Bordeaux, France

RECRUITING

Hôpital Européen Georges-Pompidou

Paris, France

RECRUITING

Dresden TUD University of Technology

Dresden, Germany

RECRUITING

Universitätsklinikum Erlangen

Erlangen, Germany

RECRUITING

Frankfurt Sankt Katharinen Krankenhaus

Frankfurt, Germany

RECRUITING

Freiburg Herzzenrtum

Freiburg im Breisgau, Germany

RECRUITING

Marienkrankenhaus Hamburg

Hamburg, Germany

RECRUITING

Herne Marien Hospital

Herne, Germany

RECRUITING

Saarland University Hospital

Homburg, Germany

RECRUITING

Herzzentrum Leipzig

Leipzig, Germany

RECRUITING

Sana Kliniken Lubeck

Lübeck, Germany

RECRUITING

Athens Hippokration

Athens, Greece

RECRUITING

University of Crete

Heraklion, Greece

RECRUITING

Thessaloniki Hippokration General Hospital

Thessaloniki, Greece

RECRUITING

Clinica Montevergine

Mercogliano, Italy

RECRUITING

Monza Policlinico

Monza, Italy

RECRUITING

Ospedale Sant'Andrea

Roma, Italy

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ajay Kirtane, MD

  Columbia University

  STUDY CHAIR

• Michel Azizi, MD

  George Pompidou Hospital

  STUDY CHAIR

• Felix Mahfoud, MD

  University of Basel

  STUDY CHAIR

Central Study Contacts

Lisa Melchior

CONTACT

651-324-4931; lisa.melchior@bsci.com

Janelle Noble

CONTACT

612-598-4368; janelle.noble@bsci.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The subjects and all study personnel taking follow-up blood pressure measurements will be blinded to the randomization up to 6 months post-randomization. Subjects will complete a blinding assessment prior to hospital discharge, at 2M and 6M FU. Study unblinding will occur at 6-months FU. ABPM measurements will be sent to an independent core lab for data cleaning and analysis and will be blinded to the randomization assignment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2:1 randomization will be used to assign subjects to treatment (RDN) or control (sham). Randomization will occur immediately after the renal angiogram.

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: August 19, 2024
• Study Start: October 3, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): August 15, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (3); US (33); FR (2); DE (9); IT (3)