Data Acquisition
OtherDevelop algorithms for determining the cardiac output through the synchronous acquisition of hemodynamic data from the pulmonary artery catheter or other pressure sensors and Impella using a network module.
Recruiting
NCT Number: NCT06308055
Abiomed Impella RT-DAQ - Observational Study
Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition
Recruiting
Interested in participating?
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Uniklinik RWTH Aachen, Aachen, North Rhine-Westphalia, Germany
Loading trial locations.
About this study
The objective of this study is to develop algorithms for determining the cardiac output through the synchronous acquisition of hemodynamic data from the pulmonary artery catheter or other pressure sensors and Impella using a network module, which can replace invasive hemodynamic monitoring in the future.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Ongoing or planned intensive care management with Impella support
- Presence or planned placement of a cardiac output measurement
- Preferentially pulmonary catheter (including cardiac output (CO) preferred as continuous measurement)
- Other means of discontinuous CO measurement incl. echocardiography, other thermodilution methods
Exclusion criteria
- Age < 18 years
- Pregnancy
- Anticipated support duration <24 h
Treatment and study plan
Primary outcomes
-
Collection of hemodynamic parameters (Cardiac Output in l/min)
Time frame: From Impella insertion unitl Impella support is permanently weaned, on average 2 days
Synchronous data acquisition of the Impella system parameters (pressure measurement, motor current, operating data) and the monitoring system (Philipps IntelliVue) using a network module (HighDim) that is connected by either a wired or wireless access.
-
Collection of hemodynamic parameters (Blood Pressure in mmHg, Pulmonary Artery Pressure in mmHg, Central Venous Pressure in mmHg, Pulmonary Capillary Wedge Pressure in mmHg)
Time frame: From Impella insertion unitl Impella support is permanently weaned, on average 2 days
Synchronous data acquisition of the Impella system parameters (pressure measurement, motor current, operating data) and the monitoring system (Philipps IntelliVue) using a network module (HighDim) that is connected by either a wired or wireless access.
-
Collection of hemodynamic parameters (Mixed Venous Saturation in %)
Time frame: From Impella insertion unitl Impella support is permanently weaned, on average 2 days
Synchronous data acquisition of the Impella system parameters (pressure measurement, motor current, operating data) and the monitoring system (Philipps IntelliVue) using a network module (HighDim) that is connected by either a wired or wireless access.
-
Collection of hemodynamic parameters (Pulmonary Vascular Resistance in In dynes/sec/cm-5 )
Time frame: From Impella insertion unitl Impella support is permanently weaned, on average 2 days
Synchronous data acquisition of the Impella system parameters (pressure measurement, motor current, operating data) and the monitoring system (Philipps IntelliVue) using a network module (HighDim) that is connected by either a wired or wireless access.
Secondary outcomes
-
Rate of Patient Survival
Time frame: Once the Impella support is permanently weaned, on average 2 days
Study contacts
Contact information is provided by the study sponsor or research team.
Andreas Goetzenich, MD, PhD, MBA, FAHA, FESC
CONTACT
Kirstin Starke
CONTACT
Sponsors and collaborators
Lead sponsor
Abiomed Inc.
Industry
Registry information
Official study title
Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Mar 13, 2024
- Registry last updated
- Jun 17, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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