TIVUS II Study
Research type
Research Study
Full title
Clinical evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for renal denervation in patients with resistant hypertension
IRAS ID
136725
Contact name
Melvin Lobo
Contact email
Sponsor organisation
Cardiosonic, Ltd.
Clinicaltrials.gov Identifier
Research summary
The TIVUS II Study is a worldwide, long term clinical study of the safety and performance of renal denervation (reduction of renal nerves activity) technology performed by the Therapeutic Intra Vascular Ultrasounds ( TIVUS™) System. Patients with resistance HTN, whose blood pressure remains high despite administrating over three anti-HTN drugs including diuretics are at higher risk of heart attack, stroke, heart failure, kidney disease and death. Aggressive treatment with lifestyle changes and drugs may not control their problem.
This study continues the evaluation of the TIVUS™ System on humans. This new treatment is based on a relatively new, but proven, technique called “renal denervation”. This treatment uses a short procedure to deliberately heating and affecting the nerves activity surrounding the renal arteries (renal denervation), using ultrasound technology. As a result of a reduction in the nerves activity, the blood pressure is reduced. This has been adapted by NICE as an optional treatment for uncontrolled patients.
The study will include up to 80 patients in Australia, Europe and Israel. They will be sub-divided to 3 cohorts, differing at their blood pressure inclusion values (>160mmHg, >140mmHg and >150mmHg with failed previous radio frequency (RF) denervation therapy). Patients found eligible will be treated. Under local anesthesia, a long catheter (hollow tube) is inserted into a blood vessel in the patient’s groin, and directed to the renal arteries. This is performed while imaging the renal arteries, using X ray. This technology uses ultrasound aimed to affect the nerves and their surrounding tissue. As opposed to currently used renal denervation technique, RF, the ultrasound doesn’t required contact with the artery wall, which may imply safer procedure, less pain and more effective.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
13/EE/0297
Date of REC Opinion
4 Nov 2013
REC opinion
Further Information Favourable Opinion