Impella Real-World Surveillance of Patients Using Sodium Bicarbonate

Last updated: August 30, 2024
Sponsor: Abiomed Inc.
Overall Status: Completed

Phase

N/A

Condition

Heart Attack (Myocardial Infarction)

Heart Failure

Circulation Disorders

Treatment

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

Impella RP with Sodium Bicarbonate used as purge solution

Clinical Study ID

NCT05820451
ABMD-CIP-21-02-SS01
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Left Sided Impella

Inclusion Criteria:

  • Left-sided Impella with bicarbonate in the purge

Exclusion

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

Total Participants: 312
Treatment Group(s): 2
Primary Treatment: Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution
Phase:
Study Start date:
December 15, 2022
Estimated Completion Date:
February 22, 2024

Connect with a study center

  • University of Alabama

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Pima Heart and Vascular (Tuscon Medical Center)

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Arkansas Heart Hospital

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Keck USC Medical Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • Advent Helath Orlando

    Orlando, Florida 32804
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Site Not Available

  • Ascension St. John Hospital

    Detroit, Michigan 48236
    United States

    Site Not Available

  • Henry Ford

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Providence St. Patrick

    Missoula, Montana 59802
    United States

    Site Not Available

  • University of Nebraska

    Omaha, Nebraska 68105
    United States

    Site Not Available

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Legacy Emanuel

    Portland, Oregon 97227
    United States

    Active - Recruiting

  • Montefiore Medical Center - Moses

    Portland, Oregon 97205
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Baylor Scott and White (Baylor Heart and Vascular)

    Dallas, Texas 75226
    United States

    Site Not Available

  • The Heart Hospital Baylor Plano

    Plano, Texas 75093
    United States

    Site Not Available

  • Providence Sacred Heart

    Spokane, Washington 99204
    United States

    Site Not Available

  • MultiCare Tacoma General

    Tacoma, Washington 98405
    United States

    Site Not Available

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