Clinical Trial

OPTIMIZE 5.5 - Optimizing Impella 5.5 Outcomes Through Advanced Data Science

Study acronym: OPTIMIZE
Recruiting
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Summary
The main goal of this observational, study is to develop a clinical decision support tool utilizing Impella 5.5 pump parameters to predict native heart recovery and prevent adverse events, by leveraging data science and real-world clinical data of cardiogenic shock patients. Therefore, secondary objectives are essential to consolidating a retrospective longitudinal analysis of Impella 5.5 pump data alongside ICU digital health record datasets to: 1. Validate the Impella 5.5 placement signal by comparing it with ICU arterial line waveforms. 2. Integrate pump data with ICU clinical data to identify patterns associated with therapy outcomes, including native heart recovery, heart replacement therapy, and mortality while on device support. 3. Define clinical scenarios linked to hemolysis, HRAEs, and arrhythmias and develop predictive models to mitigate their occurrence.
Trial Details
NCT Number NCT07619144
Lead Sponsor Medical University of Vienna
Conditions Cardiogenic Shock, Mechanical Circulatory Support, Cardiogenic Shock Post Myocardial Infarction
Enrollment 100 participants
Start Date 2026-05-08
Primary Completion 2029-01-08 (estimated)
Study Completion 2029-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-01