Impella Real-World Surveillance of Patients Using Sodium Bicarbonate

August 30, 2024 updated by: Abiomed Inc.
The population enrolled in this study are all subjects who received an Impella in which a bicarbonate-based purge solution was used.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

312

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
    • Arizona
    • Arkansas
    • California
      • Los Angeles, California, United States, 90033
    • Florida
      • Orlando, Florida, United States, 32804
      • Tampa, Florida, United States, 33606
    • Michigan
      • Detroit, Michigan, United States, 48202
      • Detroit, Michigan, United States, 48236
    • Montana
    • Nebraska
      • Omaha, Nebraska, United States, 68105
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
    • Ohio
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
      • Portland, Oregon, United States, 97205
      • Portland, Oregon, United States, 97227
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
    • Texas
      • Dallas, Texas, United States, 75226
      • Plano, Texas, United States, 75093
    • Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All subjects who received an Impella in which a bicarbonate-based purge solution was used

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From hospital admission until hospital discharge, average 5 days
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)
From hospital admission until hospital discharge, average 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abiomed Inc.

Investigators

  • Study Director: Amin Medjamia, MD, Abiomed Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Actual)

February 22, 2024

Study Completion (Actual)

February 22, 2024

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

April 7, 2023

First Posted (Actual)

April 19, 2023

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

August 30, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABMD-CIP-21-02-SS01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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