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

NCT06559891 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2026-05-05

No results posted yet for this 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 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

Conditions

Interventions

DEVICE

TIVUS™ Renal Denervation System

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

OTHER

Sham

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

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • European Cardiovascular Research Center

    collaborator NETWORK

  • IQVIA Pty Ltd

    collaborator INDUSTRY

  • SoniVie Inc.

    lead INDUSTRY

Principal Investigators

  • Ajay Kirtane, MD · Columbia University

  • Michel Azizi, MD · George Pompidou Hospital

  • Felix Mahfoud, MD · University of Basel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-03
Primary Completion
2027-03-31
Completion
2028-08-15
FDA Device
Yes

Countries

  • United States
  • France
  • Germany
  • Greece
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06559891 on ClinicalTrials.gov