OPTIMIZE 5.5 - Optimizing Impella 5.5 Outcomes Through Advanced Data Science

NCT07619144 | Recruiting FDA Device

• 1 other identifier: EK Nr: 1245/2026
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.Validate the Impella 5.5 placement signal by comparing it with ICU arterial line waveforms.
2. 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. 3.Define clinical scenarios linked to hemolysis, HRAEs, and arrhythmias and develop predictive models to mitigate their occurrence.

Conditions

Cardiogenic Shock; Mechanical Circulatory Support; Cardiogenic Shock Post Myocardial Infarction

Keywords

cardiogenic shock; mechanical circulatory support; Impella 5.5; micro-axial flow pump; data science

Outcome Measures

Primary Outcomes (1)

• Predictive Performance and Optimization of the Clinician Decision Support Tool

  The predictive performance of the developed clinical decision support tool will be evaluated by its ability to classify patient trajectories toward native heart recovery versus adverse outcomes. The model will undergo comprehensive model architecture optimization to identify the structural configuration that yields optimal performance. Model training, validation, and testing will follow a standard data split: 80% of the dataset will be utilized for training and internal validation using 5-fold cross-validation, and the remaining 20% will be held out as a definitive testing dataset. Final classification performance will be quantified using specific metrics derived from Receiver Operating Characteristic (ROC) curve analysis, including: Area Under the Curve (AUC), Sensitivity, Specificity

  From the time of Impella 5.5 insertion up to device explant (estimated average of 5 to 14 days).

Secondary Outcomes (7)

• Bias Between the Impella 5.5 Placement Signal and ICU Arterial Line Waveforms

  Continuously through the duration of active Impella 5.5 device support (from device insertion up to explant, estimated average of 5 to 14 days).

• Correlation Coefficient Between the Impella 5.5 Placement Signal and ICU Arterial Line Waveforms

  Continuously through the duration of active Impella 5.5 device support (from device insertion up to explant, estimated average of 5 to 14 days).

• Concordance Rate of Directional Trends Between the Impella 5.5 Placement Signal and ICU Arterial Line Waveforms

  Continuously through the duration of active Impella 5.5 device support (from device insertion up to explant, estimated average of 5 to 14 days).

• Percentage of Participants Exhibiting Specific Device-Support Clinical Endpoints

  Through the duration of hospital stay (estimated average of 30 days).

• Percentage of Participants Experiencing Device-Related Hemolysis

  From device insertion up to 30 days post-explant or hospital discharge, whichever occurs first.

Study Arms (3)

Native heart recovery

Patients supported with the Impella 5.5 device (J\&J MedTech) achieving native heart recovery

Device: Micro-axial flow pump support

Heart replacement therapy (durable MCS or HTX)

Patients supported with the Impella 5.5 device (J\&J MedTech) transitioning to heart replacement therapy (durable mechanical circulatory support or heart transplantation

Device: Micro-axial flow pump support

All-cause mortality

Patients supported with the Impella 5.5 device (J\&J MedTech) suffering from all-cause mortality during mechanical circulatory support.

Device: Micro-axial flow pump support

Interventions

Micro-axial flow pump support DEVICE

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.

All-cause mortality; Heart replacement therapy (durable MCS or HTX); Native heart recovery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises adult patients admitted to the intensive care unit (ICU) presenting with severe cardiogenic shock who required temporary mechanical circulatory support between January 2019 and March 2026, treated at the Medical University of Vienna, Austria. Eligible individuals are those who undergo clinical management utilizing the Impella 5.5 micro-axial flow pump as part of their standard of care. Only patients with available high-resolution pump data (downloaded from the clinical console) and ICU digital health record datasets extracted from ICCA (IntelliSpace Critical Care and Anesthesia, Philips Medical Systems Development and Manufacturing Centre, Hamburg, Germany) will be included for analysis.

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Austria

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Thomas Schlöglhofer, PhD, MSc

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Schlöglhofer, PhD, MSc

CONTACT

+4314040027280; thomas.schloeglhofer@meduniwien.ac.at

Lukas Ruoff, MSc

CONTACT

lukas.ruoff@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Technical Director Mechanical Circulatory Support Program

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 1, 2026
• Study Start: May 8, 2026
• Primary Completion (Estimated): January 8, 2029
• Study Completion (Estimated): May 30, 2029
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)