Impella Real-World Surveillance of Patients Using Sodium Bicarbonate

Abiomed

Status: Completed

Conditions: High Risk PCI; Cardiogenic Shock

Treatments: Device: Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution; Device: Impella RP with Sodium Bicarbonate used as purge solution

Study type: Observational

Funder types: Industry

Identifiers

NCT05820451

ABMD-CIP-21-02-SS01

Details and patient eligibility

About

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

Enrollment: 312 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Exclusion Criteria:

• Known pulmonary thromboemboli
• Known DVT

Trial design

312 participants in 2 patient groups

Left sided device

Description:

All patients implanted with a left sided support Impella device - this includes but is not limited to Impella 2.5, Impella CP, Impella 5.0, Impella 5.5.

Treatment:

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

Right sided device

Description:

All patients implanted with a right sided support Impella device -this includes the Impella RP

Treatment:

Device: Impella RP with Sodium Bicarbonate used as purge solution