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

NCT05372679 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

  • Uncontrolled Stage 2 Hypertension

Interventions

DEVICE

Renal denervation

The TIVUS system will be used for renal denervation

Sponsors & Collaborators

  • SoniVie Inc.

    lead INDUSTRY

Principal Investigators

  • Ajay Kirtane, MD · Columbia University/NYPH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-11
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05372679 on ClinicalTrials.gov