Stopped: The device (HeartWare) was recalled and discontinued by the FDA
Left ventricular assist device (LVAD) patients remain at risk for pump thrombus and thromboembolic events through multiple mechanisms. The HeartWare® Ventricular Assist System (HVAD®, HeartWare Inc., Framingham, MA, USA) includes a novel speed modulation feature called Lavare™ cycle. The Lavare™ Cycle is aimed to promote washing of left ventricle to decrease blood stasis and subsequent risk of thrombus formation, ingestion and/or expulsion. No prior study has prospectively evaluated the impact of Lavare™ cycle on patient outcomes in a randomized fashion. We intend to assess effects of Lavare™ Cycle among patients receiving HVAD LVAD in this randomized controlled pilot project.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Composite Endpoint of Total Ischemic Events, Thromboembolic Events, Pump Hemolysis or Thrombosis, Pump Exchange
Timeframe: 6 months