Not Yet RecruitingNot Applicable

European Study of the BrioVAD Heart Pump for Advanced Heart Failure

60 participantsStarted 2026-05-15

Plain-language summary

This clinical investigation evaluates the safety and clinical performance of the BrioVAD Left Ventricular Assist System in patients with advanced, refractory left ventricular heart failure who require mechanical circulatory support.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patient is ≥ 18 years of age.
✓. 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.
✓. Patient has a left ventricular ejection fraction (LVEF) ≤ 25% or LVEF \< 30% on inotropes or intra-aortic balloon pump (IABP).
✓. Patient is inotrope dependent, OR has a cardiac index (CI) ≤ 2.2 liters/min/m2, while not on inotropes, and also meets one of the following criteria:
✓. Is on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and is failing to respond or is not able to tolerate OMM; or
✓. Has advanced heart failure for at least 14 days and is dependent on an IABP for at least seven days.
✓. Patient has provided voluntary and informed consent.

Exclusion criteria

✕. 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 before study enrollment.
✕. Patient had cardiothoracic surgery within 30 days before implant.
✕. Patient has physiological conditions or comorbidities which pose high surgical risk or obstacles as determined by the Investigator.
✕. Patient has contraindications to warfarin anticoagulation.
✕. Patient has known hypo- or hypercoagulable state \[e.g., disseminated intravascular coagulation (DIC)\], or has a positive heparin-induced thrombocytopenia (HIT) assay and positive serotonin release assay or requires use of a non-heparin alternative anticoagulation strategy for cardiopulmonary bypass in the judgement of the Investigator.
✕. Patient is on durable MCS (e.g., LVAD or RVAD).
✕. Planned need for durable or temporary RVAD support concomitant with LVAD implant.

What they're measuring

Survival rate at 6 months

Timeframe: From enrollment to 6 months on device support

Trial details

NCT IDNCT07252531

SponsorBrioHealth BV

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07-31

View on ClinicalTrials.gov More Refractory Heart Failure trials