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ACTIVE NOT RECRUITING
NCT05372679
NA

REDUCED 1 - Renal Denervation Using Ultrasonic Catheter EmitteD Energy Study /

Sponsor: SoniVie Inc.

View on ClinicalTrials.gov

Summary

This is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System in subjects with uncontrolled stage 2 hypertension in order to assess the safety and effectiveness of the TIVUS™ System when used for renal artery denervation. The study will assess the acute and chronic safety of the procedure as well as the reduction in 24-hour ambulatory mean systolic blood pressure from baseline to 3 months after the procedure.

Official title: Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Renal Denervation in Patients With Uncontrolled Stage 2 Hypertension

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2022-11-11

Completion Date

2025-12

Last Updated

2025-12-31

Healthy Volunteers

No

Interventions

DEVICE

Renal denervation

The TIVUS system will be used for renal denervation

Locations (9)

Cardiology P.C.

Birmingham, Alabama, United States

ST Bernards Medical Center

Jonesboro, Arkansas, United States

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Bridgeport Hospital

Bridgeport, Connecticut, United States

Prairie Education and Research Cooperative

Springfield, Illinois, United States

Minneapolis Heart Institution Foundation

Minneapolis, Minnesota, United States

Columbia University/NYPH

New York, New York, United States

NC Heart and Vascular Research, LLC

Raleigh, North Carolina, United States

Medical University South Carolina

Charleston, South Carolina, United States