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NCT05372679 · ClinicalTrials.gov registry record · NA

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

A NA study of Uncontrolled Stage 2 Hypertension, sponsored by SoniVie.

Active
Registry status
NA
Development phase
25
Enrollment target
9
Study locations

NCT05372679: Active NA study of Uncontrolled Stage 2 Hypertension, sponsored by SoniVie.

NCT05372679 is a NA study of Uncontrolled Stage 2 Hypertension that is active but no longer recruiting, run by SoniVie. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05372679, a NA study of Uncontrolled Stage 2 Hypertension, is active but no longer recruiting, sponsored by SoniVie.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
25 participants
Enrollment target
9
Study locations

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.

Primary Outcome

acute treatment related adverse events including including all-cause mortality, acute kidney injury, significant embolic event, renal artery perforation or dissection requiring intervention, vascular complications, stroke, myocardial infarction, or transient ischemic attack, deterioration in renal function end-stage renal failure, hospital admission for hypertensive crisis not related to confirmed nonadherence with medications or the protocol, new renal artery stenosis of more than 70% and major

Interventions

  • DEVICE Renal denervation

Study Locations (9)

Arkansas

  • ST Bernards Medical Center - Jonesboro
  • Arkansas Heart Hospital - Little Rock

Alabama

  • Cardiology P.C. - Birmingham

Connecticut

  • Bridgeport Hospital - Bridgeport

Illinois

  • Prairie Education and Research Cooperative - Springfield

Minnesota

  • Minneapolis Heart Institution Foundation - Minneapolis

New York

  • Columbia University/NYPH - New York

North Carolina

  • NC Heart and Vascular Research, LLC - Raleigh

South Carolina

  • Medical University South Carolina - Charleston

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2022-11-11
Est. Completion 2025-12
Phase NA
SoniVie

3 total trials

What the registry record for NCT05372679 still lists

NCT05372679 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 1 condition, with Uncontrolled Stage 2 Hypertension appearing as the primary indexed condition, and to 1 intervention - of which Renal denervation is the first listed.

NCT05372679 lists 9 locations in 8 states (Arkansas, Alabama, Connecticut).

Frequently Asked Questions

What is clinical trial NCT05372679 about?

NCT05372679 is a clinical study titled "REDUCED 1 - Renal Denervation Using Ultrasonic Catheter EmitteD Energy Study /". 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 w...

What is the current status of trial NCT05372679?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2022-11-11. Estimated completion is 2025-12.

What conditions does trial NCT05372679 study?

This clinical trial studies the following conditions: Uncontrolled Stage 2 Hypertension.

What interventions are being tested in trial NCT05372679?

The interventions under investigation include: Renal denervation (DEVICE).

Who is sponsoring clinical trial NCT05372679?

This trial is sponsored by SoniVie, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05372679 being conducted?

This trial has 9 study locations across Alabama, Arkansas, Connecticut, Illinois, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT05372679's enrollment target sits among peer trials

25 1712th of 2000 higher than 265 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05372679, the US trial registry maintained by the National Library of Medicine. NCT05372679 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.