RecruitingNCT07619144

OPTIMIZE 5.5 - Optimizing Impella 5.5 Outcomes Through Advanced Data Science

Clinical Outcomes and Adverse Events Associated With Microaxial Flow Pump Support: An Explorative Retrospective Study

Sponsor

Medical University of Vienna

Enrollment

100 participants

Start Date

May 8, 2026

Study Type

OBSERVATIONAL

Conditions

Cardiogenic Shock Mechanical Circulatory Support Cardiogenic Shock Post Myocardial Infarction

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

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 Criteria3

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

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Interventions

DEVICEMicro-axial flow pump support

Temporary circulatory support using the Impella 5.5 micro-axial flow pump. The device is surgically placed (typically via the axillary artery) across the aortic valve into the left ventricle to provide active forward flow, unloading the left ventricle and maintaining systemic perfusion during cardiogenic shock. Management of the device includes the collection and analysis of continuous device-derived hemodynamic data and associated clinical parameters throughout the duration of support.