Clinical Research & Data, Surgical Applications
5.5. New opportunities in validation – The Impact Trial
Presented by Prof. Dr. Hermann Reichenspurner
Prof. Reichenspurner from Hamburg (Germany) presented the study design of the initial pilot trial of the IMpella Protected cArdiac surgery Trial (IMPACT) being a single arm study with 100 elective patients receiving Impella 5.5 or standard of care proactively in 10-15 US and European study centers prior to cardiopulmonary bypass and are weaned directly afterwards. The ratio behind is to gain evidence with Impella use on the surgical field and to avoid perioperative low cardiac output syndrome. It was discussed that the endpoint of 90 days should be prolonged to at least six months follow-up.
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