The THRIVE study is a pivotal, prospective, multicenter, 2:1 randomized, double blind, controlled, study. The objective is to compare the THerapeutic IntravasculaR Ultrasound (TIVUS ) REnal Denervation System vs. Sham for the Adjunctive Treatment of Hypertension.
Sponsor
SoniVie Ltd
Study objectives
The objective is to enroll 261 hypertensive patients (174 treated and 87 in sham group) eligible for Thrive protocol at 76 investigational sites.
Primary endpoints
- Reduction in average daytime ambulatory systolic Blood Pressure (BP) (from baseline to 2 monthspost procedure) - Efficacy endpoint
- Subject level composite of the incidence of the following Major Adverse Events (MAE) - Safety endpoint
CERC Services
- CEC and DSMB activities
- Clinical trial documentation
- Monitoring activities
- Project management
- Safety reporting
- Set-up activities (sites selection, insurance management, contract management)
- Submission to competent authorities and ethic committees
Countries
Around 8 countries across Europe, North America and Asia.
Europe: France, Germany, Greece, Switzerland, Netherland, Italy,
Asia: Israel
North America: USA
Number of investigational sites
76
Number of patients
261 (estimated)
