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THRIVE Study: TIVUS™ Renal Denervation System for High Blood Pressure

This study is testing a new treatment for high blood pressure (hypertension) called the TIVUS™ Renal Denervation System. This system uses ultrasound energy to calm overactive nerves in your kidneys that can contribute to high blood pressure. Researchers want to see if this treatment, when added to your current care, can lower your daytime blood pressure. They will also track any serious side effects. You may be eligible if you are between 22 and 75 years old, have a history of high blood pressure, and are currently taking or have previously taken blood pressure medication. The study is currently recruiting 261 participants, but its exact status is unclear.

Study design
This is an international, multi-center study where participants are randomly assigned to either receive the TIVUS™ system or a sham procedure. It is double-blind, meaning neither you nor your doctors will know which treatment you received until 6 months after the procedure.
What's involved
You would stop taking your blood pressure medications for 4 weeks before the procedure and for 2 months afterward. You will be followed for up to 36 months after the procedure.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for a maximum of 36 months after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06559891

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

Recruiting
NAAges 22–75InterventionalTreatment
SoniVie Inc.
~261 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:TIVUS™ Renal Denervation SystemSham

At a glance

Recruiting sites
50 of 50 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Reduction in average daytime ambulatory systolic BP
Measured over From baseline to 2 months post-procedure
+1 more outcome measured

Conditions

Hypertension

Explore related trials

Hypertension

Where it's being run

50 sites across 25 states
Germany9
Illinois3
Greece3
Italy3
Arkansas2
California2
Florida2
Louisiana2

Study leadership

  • Ajay Kirtane, MD · STUDY_CHAIR · Columbia University
  • Michel Azizi, MD · STUDY_CHAIR · George Pompidou Hospital
  • Felix Mahfoud, MD · STUDY_CHAIR · University of Basel

Who to contact

Lisa Melchior
[email protected]
651-324-4931
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Reduction in average daytime ambulatory systolic BPFrom baseline to 2 months post-procedure

    Primary outcome

  • Subject level composite of the incidence of Major Adverse Events (MAE)From Baseline to 30 day and 6 months post procedure

    Safety outcome