Health TrialsbyHealthPanel

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

ConditionsCardiovascular DiseasesHeart DiseasesHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorBrioHealth Solutions, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient is ≥ 18 years of age.

Patient has received institutional approval for LVAD implantation.

Patient has a body surface area (BSA) ≥ 1.2 m2.

Patient is classified as NYHA Class IV with advanced heart failure refractory to advanced heart failure management or NYHA Class III with dyspnea upon mild physical activity.

Disqualifiers

Patient's heart failure etiology is related to restrictive or constrictive physiology (e.g., nondilated hypertrophic cardiomyopathy, cardiac amyloidosis/senile or other infiltrative disease), complex congenital heart disease (e.g., transposition of the great vessels), uncorrected thyroid disease, and/or pericardial disease.

Patient had a myocardial infarction within seven days of study enrollment.

Patient had cardiothoracic surgery within 30 days of implant with the exception of a procedure to implant temporary MCS: Impella 5.5, Impella CP or TandemHeart.

Patient has physiological conditions or comorbidities which pose high surgical risk or obstacles as determined by the Investigator.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BrioVAD System

    Device

    Implantation of the BrioVAD System to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3 LVAS when used for the treatment of advanced, refractory, left ventricular heart failure.

  • HeartMate 3

    Device

    Implantation of the commercially approved HeartMate 3 LVAS, which is the standard treatment for advanced heart failure.

Treatment groups

780 Participants
are divided into 2 treatment groups
Group A: BrioVAD SystemExperimental treatment 1 intervention
Group B: HeartMate 3Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Short-Term Indication Primary Endpoint

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

Time frame
6 months
2

Long-Term Indication Primary Endpoint

Composite of survival to transplant, recovery or 24 months of LVAD support free of debilitating stroke (mRS \> 3), or reoperation to replace the pump.

Time frame
24 months

Secondary outcomes

1

Powered Secondary Endpoint

Total number of nights in hospital, skilled nursing facility, or inpatient rehabilitation, inclusive of index hospitalization, through 24 months post VAD implant, heart transplantation, VAD explant or decommission, study withdrawal, or death, whichever occurs first.

Time frame
24 months
2

Short-Term Indication Secondary Endpoint

Evaluation of the short-term safety using INTERMACS adverse event (AE) terms and definitions through 6 months post VAD implant, heart transplantation, VAD explant or decommission, study withdrawal, or death, whichever occurs first. Incidences of all AEs and the event rate per patient year of support through 6 months will be reported. Differences in the event rates between the Study Arm and the Concurrent Control Arm will be analyzed. Serious adverse events (SAEs) will be analyzed in a similar manner.

Time frame
6 months
3

Long-Term Indication Secondary Endpoint

Evaluation of the long-term safety using INTERMACS AE terms and definitions through 24 months post VAD implant, heart transplantation, VAD explant or decommission, study withdrawal, or death, whichever occurs first. Incidences of all AEs and the event rate per patient year of support through 24 months will be reported. Differences in the event rates between the Study Arm and the Concurrent Control Arm will be analyzed. SAEs will be analyzed in a similar manner

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BrioHealth Solutions, Inc.

Lead sponsor

Source ClinicalTrials.gov
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