Impella Real-World Surveillance of Patients Using Sodium Bicarbonate

Sponsor

Abiomed Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05820451

Collaborator

(none)

330

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiogenic Shock High Risk PCI	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 Design

Study Type:

Observational

Anticipated Enrollment :

330 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Impella Real-World Surveillance of Patients Using Sodium Bicarbonate

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Left sided device 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.	Device: Impella 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.
Right sided device All patients implanted with a right sided support Impella device -this includes the Impella RP	Device: Impella RP with Sodium Bicarbonate used as purge solution US commercially approved Abiomed right sided hemodynamic support devices (Impella) will be included.

Arm

Intervention/Treatment

Left sided device

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.

Device: Impella 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.

Right sided device

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

Device: Impella RP with Sodium Bicarbonate used as purge solution

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

Outcome Measures

Primary Outcome Measures

Primary Endpoint Left Sided Impella [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 [From hospital admission until hospital discharge, average 5 days]
Rate of heiarchical composite of pulmonary thromboemboli and deep vein thrombosis (DVT)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Abiomed Inc.

Investigators

Study Director: Amin Medjamia, MD, Abiomed Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abiomed Inc.

ClinicalTrials.gov Identifier:

NCT05820451

Other Study ID Numbers:

ABMD-CIP-21-02-SS01

First Posted:

Apr 19, 2023

Last Update Posted:

Apr 21, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Shock, Cardiogenic

Pharmaceutical Solutions

Study Results

No Results Posted as of Apr 21, 2023