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Impella Real-World Surveillance of Patients Using Sodium Bicarbonate

Impella Real-World Surveillance of Patients Using Sodium Bicarbonate

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05820451
Enrollment
312
Registered
2023-04-19
Start date
2022-12-15
Completion date
2024-02-22
Last updated
2024-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiogenic Shock, High Risk PCI

Brief summary

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

Interventions

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

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

DEVICEImpella RP with Sodium Bicarbonate used as purge solution

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

Sponsors

Abiomed Inc.
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Primary Endpoint Left Sided ImpellaFrom hospital admission until hospital discharge, average 5 daysRate of heiarchical composite of stroke, transient ischemic attack (TIA), left ventricular (LV) thrombus
Primary Endpoint Right Sided ImpellaFrom hospital admission until hospital discharge, average 5 daysRate of heiarchical composite of pulmonary thromboemboli and deep vein thrombosis (DVT)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026