OPTIMIZE 5.5 - Optimizing Impella 5.5 Outcomes Through Advanced Data Science
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 essentia
| Condition(s) | Cardiogenic Shock, Mechanical Circulatory Support, Cardiogenic Shock Post Myocardial Infarction |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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, HRAE |
| Who can participate | Inclusion Criteria: * 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 Exclusion Criteria: * 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Medical University of Vienna |
| Locations | Vienna, Austria |
| Start date | 2026-05-08 |
| NCT ID | NCT07619144 |
| Official listing | https://clinicaltrials.gov/study/NCT07619144 |