Impella Real-World Surveillance of Patients Using Sodium Bicarbonate
NCT ID: NCT05820451
Last Updated: 2024-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
312 participants
OBSERVATIONAL
2022-12-15
2024-02-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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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.
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
Impella RP with Sodium Bicarbonate used as purge solution
US commercially approved Abiomed right sided hemodynamic support devices (Impella) will be included.
Interventions
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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.
Impella RP with Sodium Bicarbonate used as purge solution
US commercially approved Abiomed right sided hemodynamic support devices (Impella) will be included.
Eligibility Criteria
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Inclusion Criteria
* Right-sided Impella with bicarbonate in the purge
Exclusion Criteria
Right Sided Impella
* Known pulmonary thromboemboli
* Known DVT
ALL
No
Sponsors
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Abiomed Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Amin Medjamia, MD
Role: STUDY_DIRECTOR
Abiomed Inc.
Locations
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University of Alabama
Birmingham, Alabama, United States
Pima Heart and Vascular (Tuscon Medical Center)
Tucson, Arizona, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Keck USC Medical Center
Los Angeles, California, United States
Advent Helath Orlando
Orlando, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Henry Ford
Detroit, Michigan, United States
Ascension St. John Hospital
Detroit, Michigan, United States
Providence St. Patrick
Missoula, Montana, United States
University of Nebraska
Omaha, Nebraska, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Christ Hospital
Cincinnatti, Ohio, United States
Montefiore Medical Center - Moses
Portland, Oregon, United States
Legacy Emanuel
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Baylor Scott and White (Baylor Heart and Vascular)
Dallas, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
Providence Sacred Heart
Spokane, Washington, United States
MultiCare Tacoma General
Tacoma, Washington, United States
Countries
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Other Identifiers
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ABMD-CIP-21-02-SS01
Identifier Type: -
Identifier Source: org_study_id
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