Abiomed Impella RT-DAQ - Observational Study

Cardiogenic Shock Clinical Trial

Official title:

Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06308055
• Other study ID #: 2022-R01
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: March 2024
• Source: Abiomed Inc.
• Contact: Andreas Goetzenich, MD, PhD, MBA, FAHA, FESC
• Phone: +49 241 8860
• Email: agoetzenich[@]abiomed.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Ongoing or planned intensive care management with Impella support

2. Presence or planned placement of a cardiac output measurement

1. Preferentially pulmonary catheter (including cardiac output (CO) preferred as continuous measurement)

2. Other means of discontinuous CO measurement incl. echocardiography, other thermodilution methods

Exclusion Criteria:

1. Age < 18 years

2. Pregnancy

3. Anticipated support duration <24 h

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock, Cardiogenic

Intervention

Other:
• Data Acquisition
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abiomed Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	Rate of Patient Survival		Once the Impella support is permanently weaned, on average 2 days