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Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data Acquisition | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Impella insertion unitl Impella support is permanently weaned, on average 2 days |
| 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. | From Impella insertion unitl Impella support is permanently weaned, on average 2 days |
| 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. | From Impella insertion unitl Impella support is permanently weaned, on average 2 days |
| 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. | From Impella insertion unitl Impella support is permanently weaned, on average 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Patient Survival | Once the Impella support is permanently weaned, on average 2 days |
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Inclusion Criteria:
Ongoing or planned intensive care management with Impella support
Presence or planned placement of a cardiac output measurement
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Goetzenich, MD, PhD, MBA, FAHA, FESC | Contact | +49 241 8860 | 0 | AGoetze1@ITS.JNJ.com |
| Kirstin Starke | Contact | +49 241 8860 | 0 | KStarke@ITS.JNJ.com |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Kersten, MD | Uniklinik RWTH Aachen, Klinik für Kardiologie, Angiologie und Internistische Intensivmedizin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniklinik RWTH Aachen | Active, not recruiting | Aachen | North Rhine-Westphalia | 52074 | Germany | |
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| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| UKSH Campus Kiel |
| Not yet recruiting |
| Kiel |
| Schleswig-Holstein |
| 24105 |
| Germany |
|
| IRCCS Ospedale San Raffaele | Not yet recruiting | Milan | MI | 20132 | Italy |
|
| Universitätsspital Basel | Recruiting | Basel | Switzerland |
|
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |