This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the HeartWare® Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart failure
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Must be ≥18 years of age at consent
✓. Subjects with advanced heart failure symptoms (Class IIIB or IV) who meet one of the following):
✓. on optimal medical management including dietary salt restriction and diuretics, for at least 45 out of the last 60 days and are failing to respond; or
✓. in Class III or Class IV heart failure for at least 14 days and dependent on intra-aortic balloon pump (IABP) and/or inotropes.
✓. Left ventricular ejection fraction ≤25%.
✓. Female subjects of childbearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) for the duration of the study.
✓. The subject has signed the informed consent form.
Exclusion criteria
✕. Body Mass Index (BMI) \> 47.
✕. Body Surface Area (BSA) \< 1.0 m2.
✕. Partial or full mechanical circulatory support within thirty days of implant.
✕. Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP) or TandemHeart PTVA®.
. History of confirmed, untreated abdominal or thoracic aortic aneurysm (diameter \> 5 cm).
✕. Acute myocardial infarction within 14 days of implant as diagnosed by ST or T wave changes on the electrocardiogram (ECG), diagnostic biomarkers, ongoing pain and hemodynamic abnormalities.
✕. On ventilator support for \> 72 hours within the four days immediately prior to implant.