NCT06559891

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

A Pivotal, Prospective, Multicenter, 2:1 Randomized, Double Blind, Controlled, Study Comparing the THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension (The THRIVE Study)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 261 (estimated)
• Sponsor: SoniVie Inc. · Industry
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

THRIVE is an international, multicenter, randomized, double blind, sham-controlled study, designed to demonstrate the adjunctive effectiveness and safety of the TIVUS System in hypertensive subjects while subjects are maintained off-antihypertensive medications for a 4-week wash-out period before RDN/Sham procedure and 2 months after procedure. At two months after procedure, subjects with uncontrolled hypertension are put back on antihypertensive medication according to a medication escalation protocol. Unblinding will be performed at 6 months. Uncontrolled sham subjects can cross-over to RDN procedure at 6-months. The sham procedure will be minimally invasive to reduce risk to subjects. All subjects treated with TIVUS will be followed for a maximum of 36 months post procedure.

Conditions

• Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-03
• Primary completion: 2027-02-28
• Completion: 2028-08-15
• First posted: 2024-08-19
• Last updated: 2026-04-02

Locations

49 sites across 5 countries: United States, France, Germany, Greece, Italy

Regulatory

• FDA-regulated device study