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)

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

Description

Eligibility

Age range

22–75 years

Sex

All

Healthy volunteers

No

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.

Locations (50)