European Study of the BrioVAD Heart Pump for Advanced Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrioHealth BV
About this trial
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.
Eligibility criteria
Qualifiers
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).
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 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.
Trial design
Treatments tested in this trial
- LVAD implantation
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
BrioHealth BV
Lead sponsor
Meditrial SrL
Collaborator
Source ClinicalTrials.gov