OPTIMIZE 5.5 - Optimizing Impella 5.5 Outcomes Through Advanced Data Science

Recruiting now

Conditions studied: Cardiogenic Shock, Mechanical Circulatory Support, Cardiogenic Shock Post Myocardial Infarction

In brief

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.

Key facts

Study ID: NCT07619144
Run by: Medical University of Vienna
People needed: 100
Starts: 2026-05-08
Expected to finish: 2029-05-30
Last updated by the study team: 2026-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adult patients who were treated for cardiogenic shock and supported with an Impella 5.5 micro-axial flow pump
Only patients with available high-resolution pump data (downloaded from the clinical console) and ICU digital health record datasets

You may not qualify if…

Patients supported with an Impella 5.5 for indications other than cardiogenic shock (e.g., protected PCI or CABG)
Patients younger than 18 years
Patients with incomplete data, procedural records, or demographic information

Where it is running

Medical University of Vienna — Vienna, Austria (enrolling)

Full record on ClinicalTrials.gov

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