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NCT06559891 · ClinicalTrials.gov registry record · NA

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

A NA study of Hypertension, sponsored by SoniVie.

Recruiting
Registry status
NA
Development phase
261
Enrollment target
20
Study locations

NCT06559891: Recruiting NA study of Hypertension, sponsored by SoniVie.

NCT06559891 is a NA study of Hypertension that is actively recruiting participants, run by SoniVie. The registered enrollment target is 261 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06559891, a NA study of Hypertension, is actively recruiting participants, sponsored by SoniVie.

RECRUITING
Registry status
NA
Development phase
261 participants
Enrollment target
20
Study locations

Study 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 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

Primary Outcome

Primary outcome

Conditions Studied

Interventions

  • OTHER Sham
  • DEVICE TIVUS™ Renal Denervation System

Study Locations (20)

Illinois

  • Ascension Alexian Brothers - Elk Grove Village
  • St. John's Prairie Heart - Springfield
  • Southern Illinois University, School of Medicine - Springfield

Arkansas

  • St. Bernard's Medical Center - Jonesboro
  • Arkansas Heart Hospital - Little Rock

California

  • Cedar-Sinai Medical Center - Los Angeles
  • Stanford University - Stanford

Florida

  • Ascension- Sacred Heart - Pensecola
  • University of South Florida - Tampa

Louisiana

  • Cardiovascular Institute of the South - Houma
  • Ochsner Medical Center - New Orleans

Michigan

  • Henry Ford Hospital - Detroit
  • Henry Ford Providence Hospital - Southfield

Mississippi

  • Gulfport Memorial Hospital - Gulfport
  • Jackson Heart - Jackson

Missouri

  • St. Luke's Hospital - Kansas City
  • St Lukes Hospital - Kansas City

Trial Details

FieldValue
Enrollment Target 261 participants
Start Date 2024-10-03
Est. Completion 2028-08-15
Phase NA
SoniVie

3 total trials

What NCT06559891 shows while recruiting

NCT06559891 is an interventional study that assigns participants to a tested intervention. The registered 261 participants enrollment target is mid-sized for trials with a published cap, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (93% lower).

The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Sham is the first listed.

NCT06559891 names 20 study sites across 11 states, led by Illinois, Arkansas, California.

Frequently Asked Questions

What is clinical trial NCT06559891 about?

NCT06559891 is a clinical study titled "THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension". 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 hypertension (HTN) receiving up to 2 anti-hypertensive drugs of different classes in whom the anti-hypertensive medications will be stopped for a ...

What is the current status of trial NCT06559891?

This trial is currently recruiting. It is a NA study. The enrollment target is 261 participants. The study started on 2024-10-03. Estimated completion is 2028-08-15.

What conditions does trial NCT06559891 study?

This clinical trial studies the following conditions: Hypertension.

What interventions are being tested in trial NCT06559891?

The interventions under investigation include: Sham (OTHER), TIVUS™ Renal Denervation System (DEVICE).

Who is sponsoring clinical trial NCT06559891?

This trial is sponsored by SoniVie, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06559891 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Hypertension

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06559891's enrollment target sits among peer trials

261 190th of 470 higher than 281 of 470 other Hypertension trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06559891, the US trial registry maintained by the National Library of Medicine. NCT06559891 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.