Impella Real-World Surveillance of Patients Using Sodium Bicarbonate

The population enrolled in this study are all subjects who received an Impella in which a bicarbonate-based purge solution was used.

Completed

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Key information

Conditions

Cardiogenic Shock Cardiovascular Diseases Heart Diseases High Risk PCI Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Left Sided Impella

Inclusion criteria

Left-sided Impella with bicarbonate in the purge

Exclusion criteria

Known LV thrombus

Right Sided Impella

Inclusion criteria

Right-sided Impella with bicarbonate in the purge

Exclusion criteria

Known pulmonary thromboemboli
Known DVT

Treatment and study plan

Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution

Device

US commercially approved Abiomed left sided hemodynamic support devices (Impella) will be included.

Impella RP with Sodium Bicarbonate used as purge solution

Device

US commercially approved Abiomed right sided hemodynamic support devices (Impella) will be included.

Primary outcomes

Primary Endpoint Left Sided Impella

Time frame: From hospital admission until hospital discharge, average 5 days

Rate of heiarchical composite of stroke, transient ischemic attack (TIA), left ventricular (LV) thrombus
Primary Endpoint Right Sided Impella

Time frame: From hospital admission until hospital discharge, average 5 days

Rate of heiarchical composite of pulmonary thromboemboli and deep vein thrombosis (DVT)

Sponsors and collaborators

Lead sponsor

Abiomed Inc.

Industry

Registry information

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Apr 19, 2023
Registry last updated: Sep 4, 2024

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.

Published trials that share one or more normalized conditions with this study.

Completed