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Heart Diseases / BrioVAD System / Heart Failure · Interventional Study
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for an active, ongoing, non-inferiority trial comparing the BrioVAD System to HeartMate 3 in advanced left ventricular heart failure. No results have been posted or analysed; the study is currently recruiting and primary endpoints will not be evaluated until 24 months of follow-up are complete.
Interventional, Randomized, Parallel, Open label, Treatment purpose. Cardiovascular Diseases, Heart Diseases, Heart Failure; age from 18 Years; to 100 Years. Intervention: BrioVAD System. Compared with: HeartMate 3 — Active Comparator. n = 780. 47 sites: United States.
This is a registry record for an active, ongoing, non-inferiority trial comparing the BrioVAD System to HeartMate 3 in advanced left ventricular heart failure. No results have been posted or analysed; the study is currently recruiting and primary endpoints will not be evaluated until 24 months of follow-up are complete.
This is a registry record only; no efficacy or safety results have been reported
The source did not state who this applies to in practice.
This is a clinical trial registry record with no reported results; the study is actively recruiting and outcomes have not yet been posted or analysed.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06310031). This is a study registration, not published results. Lead sponsor: BrioHealth Solutions, Inc.. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 780 participants (ESTIMATED). Conditions: Cardiovascular Diseases, Heart Diseases, Heart Failure. Interventions: DEVICE: BrioVAD System; DEVICE: HeartMate 3. Primary outcome measures: Short-Term Indication Primary Endpoint , 6 months; Long-Term Indication Primary Endpoint , 24 months. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.