Impella Real-World Surveillance of Patients Using Sodium Bicarbonate

Recruiting

• Conditions: Cardiogenic Shock; High Risk PCI

• Registration Number: NCT05820451
• Lead Sponsor: Abiomed Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-15
• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-04-07
• Study First Posted: 2023-04-19
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
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