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NCT06310031 · ClinicalTrials.gov registry record · NA

Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure

A NA study of Heart Failure and Cardiovascular Diseases, sponsored by BrioHealth Solutions.

Recruiting
Registry status
NA
Development phase
780
Enrollment target
20
Study locations

NCT06310031 is a NA study of Heart Failure and Cardiovascular Diseases that is actively recruiting participants, run by BrioHealth Solutions. The registered enrollment target is 780 participants, below the 2,047-participant average among 397 other Heart Failure trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT06310031, a NA study of Heart Failure and Cardiovascular Diseases, is actively recruiting participants, sponsored by BrioHealth Solutions.

RECRUITING
Registry status
NA
Development phase
780 participants
Enrollment target
20
Study locations

Study Summary

The goal of this study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3 Left Ventricular Assist System when used for the treatment of advanced, refractory, left ventricular heart failure.

Interventions

  • DEVICE BrioVAD System
  • DEVICE HeartMate 3

Study Locations (20)

Illinois

  • Advocate Christ Medical Center - Chicago
  • Northwestern University - Chicago
  • University of Chicago - Chicago

Michigan

  • University of Michigan - Ann Arbor
  • Henry Ford Health - Detriot
  • Corewell Health Grand Rapids Hospital - Grand Rapids

Florida

  • UF Health Shands Hospital - Gainsville
  • Advent Health - Orlando

Georgia

  • Piedmont Healthcare - Atlanta
  • Emory University - Atlanta

Minnesota

  • Abbott Northwestern Hospital - Minneapolis
  • University of Minnesota - Minneapolis

Arkansas

  • Baptist Health Medical Center-Little Rock - Little Rock

Indiana

  • Ascension St. Vincent Hospital - Indianapolis - Indianapolis

Kentucky

  • University of Louisville - Louisville

Trial Details

FieldValue
Enrollment Target 780 participants
Start Date 2024-10-28
Est. Completion 2028-12
Phase NA

Sponsor

BrioHealth Solutions

1 total trials

What the Registry Record Tells You About NCT06310031

The ClinicalTrials.gov registry entry for NCT06310031 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 780 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,047-participant average among 397 other Heart Failure trials with a reported enrollment target (62% lower). The listed sponsor is BrioHealth Solutions, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which BrioVAD System is the first listed.

NCT06310031 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Illinois, Michigan, Florida.

Frequently Asked Questions

What is clinical trial NCT06310031 about?

NCT06310031 is a clinical study titled "Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure". The goal of this study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3 Left Ventricular Assist System when used for the treatment of advanced, refractory, left ventricular heart failure.

What is the current status of trial NCT06310031?

This trial is currently recruiting. It is a NA study. The enrollment target is 780 participants. The study started on 2024-10-28. Estimated completion is 2028-12.

What conditions does trial NCT06310031 study?

This clinical trial studies the following conditions: Heart Failure, Cardiovascular Diseases, Heart Diseases.

What interventions are being tested in trial NCT06310031?

The interventions under investigation include: BrioVAD System (DEVICE), HeartMate 3 (DEVICE).

Who is sponsoring clinical trial NCT06310031?

This trial is sponsored by BrioHealth Solutions, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06310031 being conducted?

This trial has 20 study locations across Arkansas, Florida, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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