Cardiogenic ShockOPTIMIZENCT07619144
OPTIMIZE 5.5 - Optimizing Impella 5.5 Outcomes Through Advanced Data Science
An observational study of Cardiogenic Shock and Mechanical Circulatory Support, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Mechanical Circulatory Support, Cardiogenic Shock Post Myocardial Infarction
- What is being tested?
- Micro-axial flow pump support
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 8 May 2026to 30 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lukas Ruoff, MSc contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna
Thomas Schlöglhofer, PhD, MSc, +4314040027280, thomas.schloeglhofer@meduniwien.ac.at
Lukas Ruoff, MSc, lukas.ruoff@meduniwien.ac.at
About this study
Official title: Clinical Outcomes and Adverse Events Associated With Microaxial Flow Pump Support: An Explorative Retrospective Study
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:
- Validate the Impella 5.5 placement signal by comparing it with ICU arterial line waveforms.
- 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.
- Define clinical scenarios linked to hemolysis, HRAEs, and arrhythmias and develop predictive models to mitigate their occurrence.
Read the detailed description
The clinical management of patients experiencing severe cardiogenic shock requires precise, real-time monitoring to optimize hemodynamic support and guide therapeutic transitions. The Impella 5.5 micro-axial flow pump provides left ventricular unloading, generating automated internal continuous parameters that reflect moving cardiac states. This study establishes a retrospective, longitudinal framework that integrates these high-frequency device metrics with corresponding clinical data housed within intensive care unit (ICU) digital health records (DHR). By synthesizing these disparate data streams, this research aims to build an advanced analytical framework to support clinical decisions in the cardiogenic shock landscape.
Signal Validation and Data Preprocessing:
The initial phase of the study validates the physiological fidelity of the continuous data stream. High-frequency digital logs generated by the pump console-specifically the optical placement signal-will undergo time-series alignment with standard physiological waveforms recorded in the ICU, using indwelling arterial line pressure data as the reference standard. This signal validation ensures that the longitudinal parameter data accurately capture mechanical positioning and true left ventricular dynamics prior to entering the downstream modeling pipeline.
Analytical Framework and Modeling Strategy:
Following data integration and signal validation, the consolidated dataset will be leveraged to develop predictive models aimed at distinguishing patient trajectories and forecasting complications. The computational pipeline is divided into two primary analytical pathways:
Endpoint Classification:
An artificial neural network will be developed to evaluate patient trajectories toward distinct clinical endpoints: native heart recovery, escalation to heart replacement therapy, or death. The modeling pipeline incorporates a rigorous framework to ensure generalizability and guard against overfitting. The complete dataset will be partitioned into an 80% development subset and a 20% independent testing subset. The development subset will undergo 5-fold cross-validation to drive comprehensive model architecture optimization, systematically testing structural variations to identify the highest-performing network configuration.
Adverse Event Forecasting:
Separate statistical and machine learning architectures will be constructed to evaluate risk patterns and clinical scenarios associated with severe on-device complications, specifically clinical hemolysis, new-onset arrhythmias, and hemocompatibility-related adverse events (HRAEs). These models focus on identifying early-warning clusters within the high-frequency pump log data to identify sub-clinical changes before manifest physiological degradation occurs.
Through these combined pathways, this observational study seeks to lay the foundational algorithmic groundwork for a real-time clinical decision support tool utilizing objective, automated device analytics to improve safety and personalization in mechanical circulatory support.
- Conditions
- Cardiogenic Shock, Mechanical Circulatory Support, Cardiogenic Shock Post Myocardial Infarction
- Being tested
- Micro-axial flow pump support
- Keywords
- cardiogenic shock, mechanical circulatory support, Impella 5.5, micro-axial flow pump, data science
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-axial flow pump supportDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Native heart recovery | Patients supported with the Impella 5.5 device (J\&J MedTech) achieving native heart recovery Receives: 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 Receives: 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. Receives: Device: Micro-axial flow pump support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
The systematic difference (bias) between the automated Impella 5.5 optical placement signal and the gold-standard ICU indwelling arterial line pressure waveforms will be quantified using Bland-Altman analysis to evaluate signal alignment.
Unit of Measure: Millimeters of mercury (mmHg)
Measured: 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
The strength and direction of the linear relationship between the continuous time-series data of the Impella 5.5 optical placement signal and the ICU arterial line waveforms will be evaluated.
Unit of Measure: Correlation coefficient (r) on a scale from -1.0 to 1.0.
Measured: 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
The trending ability of the placement signal will be assessed via concordance plots. The concordance rate represents the percentage of data points where the directional change (increase or decrease) matches between both signal streams over time, excluding zones of clinical noise.
Unit of Measure: Percentage (%) of concordant data pairs.
Measured: 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
The final clinical trajectory of the cohort on device support will be categorized into one of three mutually exclusive outcomes:
- Native heart recovery (successful device weaning and explant)
- Escalation to heart replacement therapy (durable LVAD implantation or heart transplantation)
- All-cause mortality while on active device support.
Unit of Measure: Percentage (%) of participants within each categorical outcome category.
Measured: Through the duration of hospital stay (estimated average of 30 days).
Percentage of Participants Experiencing Device-Related Hemolysis
The incidence of clinically significant hemolysis on device support, defined by standard laboratory criteria (e.g., plasma free hemoglobin greater than 40 mg/dL or a doubling of lactate dehydrogenase alongside clinical signs).
Unit of Measure: Percentage (%) of participants.
Measured: From device insertion up to 30 days post-explant or hospital discharge, whichever occurs first.
Percentage of Participants Experiencing New-Onset Clinically Significant Arrhythmias
The incidence of new-onset atrial or ventricular arrhythmias occurring during device support that require immediate pharmacological, electrical, or device-setting intervention.
Unit of Measure: Percentage (%) of participants.
Measured: From device insertion up to 30 days post-explant or hospital discharge, whichever occurs first.
Number of Hemocompatibility-Related Adverse Events (HRAEs) Per Participant
The rate of hemocompatibility-related adverse events, including major bleeding episodes (requiring transfusion or reoperation) and thromboembolic events (e.g., ischemic stroke, peripheral arterial embolization) occurring during device support.
Unit of Measure: Number of events per participant.
Measured: From device insertion up to 30 days post-explant or hospital discharge, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start8 May 2026
- Primary completion8 Jan 2029 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Schlöglhofer, PhD, MSc, Medical University of Vienna
- Investigators
- Thomas Schlöglhofer, PhD, MSc, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619144
- Sponsor's protocol ID
- EK Nr: 1245/2026
- Acronym
- OPTIMIZE
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared because the dataset contains highly sensitive, high-frequency physiological data linked with intensive care health records. Further, IPD is currently not planned for public sharing as the dataset is being actively used to develop a proprietary clinical decision support tool and model architecture optimization.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes and Adverse Events Associated With Microaxial Flow Pump Support: An Explorative Retrospective Study
- ClinicalTrials.gov ID
- NCT07619144
- Acronym / sponsor ID
- OPTIMIZE / EK Nr: 1245/2026
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 8 May 2026 (actual)
- Primary completion
- 8 Jan 2029 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Validate the Impella 5.5 placement signal by comparing it with ICU arterial line waveforms.
- 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.
- Define clinical scenarios linked to hemolysis, HRAEs, and arrhythmias and develop predictive models to mitigate their occurrence.
Detailed description
The clinical management of patients experiencing severe cardiogenic shock requires precise, real-time monitoring to optimize hemodynamic support and guide therapeutic transitions. The Impella 5.5 micro-axial flow pump provides left ventricular unloading, generating automated internal continuous parameters that reflect moving cardiac states. This study establishes a retrospective, longitudinal framework that integrates these high-frequency device metrics with corresponding clinical data housed within intensive care unit (ICU) digital health records (DHR). By synthesizing these disparate data streams, this research aims to build an advanced analytical framework to support clinical decisions in the cardiogenic shock landscape.
Signal Validation and Data Preprocessing:
The initial phase of the study validates the physiological fidelity of the continuous data stream. High-frequency digital logs generated by the pump console-specifically the optical placement signal-will undergo time-series alignment with standard physiological waveforms recorded in the ICU, using indwelling arterial line pressure data as the reference standard. This signal validation ensures that the longitudinal parameter data accurately capture mechanical positioning and true left ventricular dynamics prior to entering the downstream modeling pipeline.
Analytical Framework and Modeling Strategy:
Following data integration and signal validation, the consolidated dataset will be leveraged to develop predictive models aimed at distinguishing patient trajectories and forecasting complications. The computational pipeline is divided into two primary analytical pathways:
Endpoint Classification:
An artificial neural network will be developed to evaluate patient trajectories toward distinct clinical endpoints: native heart recovery, escalation to heart replacement therapy, or death. The modeling pipeline incorporates a rigorous framework to ensure generalizability and guard against overfitting. The complete dataset will be partitioned into an 80% development subset and a 20% independent testing subset. The development subset will undergo 5-fold cross-validation to drive comprehensive model architecture optimization, systematically testing structural variations to identify the highest-performing network configuration.
Adverse Event Forecasting:
Separate statistical and machine learning architectures will be constructed to evaluate risk patterns and clinical scenarios associated with severe on-device complications, specifically clinical hemolysis, new-onset arrhythmias, and hemocompatibility-related adverse events (HRAEs). These models focus on identifying early-warning clusters within the high-frequency pump log data to identify sub-clinical changes before manifest physiological degradation occurs.
Through these combined pathways, this observational study seeks to lay the foundational algorithmic groundwork for a real-time clinical decision support tool utilizing objective, automated device analytics to improve safety and personalization in mechanical circulatory support.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Native heart recovery | – | Device: Micro-axial flow pump supportPatients supported with the Impella 5.5 device (J\&J MedTech) achieving native heart recovery |
| Heart replacement therapy (durable MCS or HTX) | – | Device: Micro-axial flow pump supportPatients supported with the Impella 5.5 device (J\&J MedTech) transitioning to heart replacement therapy (durable mechanical circulatory support or heart transplantation |
| All-cause mortality | – | Device: Micro-axial flow pump supportPatients supported with the Impella 5.5 device (J\&J MedTech) suffering from all-cause mortality during mechanical circulatory support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micro-axial flow pump supportTemporary 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. | Device | All-cause mortality, Heart replacement therapy (durable MCS or HTX), Native heart recovery |
Primary outcome
Predictive Performance and Optimization of the Clinician Decision Support Tool
Time frame: From the time of Impella 5.5 insertion up to device explant (estimated average of 5 to 14 days).
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
7 secondary outcomes
Bias Between the Impella 5.5 Placement Signal and ICU Arterial Line Waveforms
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through the duration of hospital stay (estimated average of 30 days).
Percentage of Participants Experiencing Device-Related Hemolysis
Time frame: From device insertion up to 30 days post-explant or hospital discharge, whichever occurs first.
Percentage of Participants Experiencing New-Onset Clinically Significant Arrhythmias
Time frame: From device insertion up to 30 days post-explant or hospital discharge, whichever occurs first.
Number of Hemocompatibility-Related Adverse Events (HRAEs) Per Participant
Time frame: From device insertion up to 30 days post-explant or hospital discharge, whichever occurs first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No. IPD will not be shared because the dataset contains highly sensitive, high-frequency physiological data linked with intensive care health records. Further, IPD is currently not planned for public sharing as the dataset is being actively used to develop a proprietary clinical decision support tool and model architecture optimization.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lukas Ruoff, MSc contact
Thomas Schlöglhofer, PhD, MSc principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock and Mechanical Circulatory Support, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Schlöglhofer, PhD, MSc (+4314040027280, thomas.schloeglhofer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Performance and Optimization of the Clinician Decision Support Tool (time frame: From the time of Impella 5.5 insertion up to device explant (estimated average of 5 to 14 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.