NCT07619144 OPTIMIZE 5.5 - Optimizing Impella 5.5 Outcomes Through Advanced Data Science
| NCT ID | NCT07619144 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Vienna |
| Condition | Cardiogenic Shock |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-05-08 |
| Primary Completion | 2029-01-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-05-08 with a primary completion date of 2029-01-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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 Criteria
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
Contact & Investigator
Thomas Schlöglhofer, PhD, MSc
PRINCIPAL INVESTIGATOR
Medical University of Vienna
Frequently Asked Questions
Who can join the NCT07619144 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiogenic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07619144 currently recruiting?
Yes, NCT07619144 is actively recruiting participants. Contact the research team at thomas.schloeglhofer@meduniwien.ac.at for enrollment information.
Where is the NCT07619144 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT07619144 clinical trial?
NCT07619144 is sponsored by Medical University of Vienna. The principal investigator is Thomas Schlöglhofer, PhD, MSc at Medical University of Vienna. The trial plans to enroll 100 participants.