Abiomed Impella RT-DAQ - Observational Study
ConditionCardiogenic Shock
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbiomed Inc.
About this trial
Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age < 18 years
Pregnancy
Anticipated support duration <24 h
Trial population
Patients requiring cardiac Impella pump-support and intensive care therapy including cardiac output monitoring, eg. by pulmonary artery catheter at some point of therapy. Initially, a collection of 250 patient days is aimed for. It is expected that each patient will be monitored by PAC for at least 48 hours, thus approximately 125 patients will be needed to achieve study objectives.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Data Acquisition
Other interventionDevelop 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Collection of hemodynamic parameters (Cardiac Output in l/min)
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.
Time frame
From Impella insertion unitl Impella support is permanently weaned, on average 2 days2
Collection of hemodynamic parameters (Blood Pressure in mmHg, Pulmonary Artery Pressure in mmHg, Central Venous Pressure in mmHg, Pulmonary Capillary Wedge Pressure in mmHg)
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.
Time frame
From Impella insertion unitl Impella support is permanently weaned, on average 2 days3
Collection of hemodynamic parameters (Mixed Venous Saturation in %)
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.
Time frame
From Impella insertion unitl Impella support is permanently weaned, on average 2 days4
Collection of hemodynamic parameters (Pulmonary Vascular Resistance in In dynes/sec/cm-5 )
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.
Time frame
From Impella insertion unitl Impella support is permanently weaned, on average 2 daysSecondary outcomes
1
Rate of Patient Survival
Time frame
Once the Impella support is permanently weaned, on average 2 daysSponsors and contacts
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Source ClinicalTrials.gov