Abiomed Impella RT-DAQ - Observational Study

Recruiting

• Conditions: Cardiogenic Shock

• Registration Number: NCT06308055
• Lead Sponsor: Abiomed Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-13
• Study Start: 2024-10-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-29
• Last Update Posted: 2024-12-03
• Primary Completion: 2025-12-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collection of hemodynamic parameters (Cardiac Output in l/min)	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)	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 %)	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 )	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 Outcome Measures

Name	Time	Method
Rate of Patient Survival	Once the Impella support is permanently weaned, on average 2 days

Trial Locations

Locations (1)

Universitätsspital Basel; 🇨🇭 Basel, Switzerland