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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: Recruiting NA study of Heart Failure and Cardiovascular Diseases, sponsored by BrioHealth Solutions.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Composite of survival to transplant, recovery or 6 months of LVAD support free of debilitating stroke \[modified Rankin Scale (mRS) \> 3\], or reoperation to replace the pump
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 780 participants |
| Start Date | 2024-10-28 |
| Est. Completion | 2028-12 |
| Phase | NA |
What NCT06310031 shows while recruiting
NCT06310031 is an interventional study that assigns participants to a tested intervention. The registered 780 participants enrollment target is mid-sized for trials with a published cap, below the 2,047-participant average among 397 other Heart Failure trials with a reported enrollment target (62% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06310031's enrollment target sits among peer trials
780 80th of 397 higher than 318 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure 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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