Impella Real-World Surveillance of Patients Using Sodium Bicarbonate

NCT05820451 — Completed, 312 participants, Abiomed Inc.
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RegistryNCT05820451
StatusCompleted
Study typeObservational
Enrollment312 (Actual)
SponsorAbiomed Inc. (Industry)
ConditionsCardiogenic Shock, High Risk PCI
InterventionsImpella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution, Impella RP with Sodium Bicarbonate used as purge solution (Device)
Datesstart 2022-12-15, primary completion 2024-02-22, completion 2024-02-22, first posted 2023-04-19, last updated 2024-09-04
Locations20 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Cardiogenic Shock All trials for High Risk PCI All trials of Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution All trials of Impella RP with Sodium Bicarbonate used as purge solution

-Summary

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

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+Arms and interventions

ArmTypeInterventionsDescription
Left sided deviceDevice: Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solutionAll 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.
Right sided deviceDevice: Impella RP with Sodium Bicarbonate used as purge solutionAll patients implanted with a right sided support Impella device -this includes the Impella RP
  • Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution (Device): US commercially approved Abiomed left sided hemodynamic support devices (Impella) will be included.
  • Impella RP with Sodium Bicarbonate used as purge solution (Device): US commercially approved Abiomed right sided hemodynamic support devices (Impella) will be included.

+Outcome measures

Primary outcomes

  • 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

Sex: All

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

+Locations (20)

FacilityCityCountryStatus
University of AlabamaBirmingham, AlabamaUnited States
Pima Heart and Vascular (Tuscon Medical Center)Tucson, ArizonaUnited States
Arkansas Heart HospitalLittle Rock, ArkansasUnited States
Keck USC Medical CenterLos Angeles, CaliforniaUnited States
Advent Helath OrlandoOrlando, FloridaUnited States
Tampa General HospitalTampa, FloridaUnited States
Henry FordDetroit, MichiganUnited States
Ascension St. John HospitalDetroit, MichiganUnited States
Providence St. PatrickMissoula, MontanaUnited States
University of NebraskaOmaha, NebraskaUnited States
Robert Wood Johnson University HospitalNew Brunswick, New JerseyUnited States
Christ HospitalCincinnatti, OhioUnited States
Montefiore Medical Center - MosesPortland, OregonUnited States
Legacy EmanuelPortland, OregonUnited States
Oregon Health & Science UniversityPortland, OregonUnited States
UPMC PresbyterianPittsburgh, PennsylvaniaUnited States
Baylor Scott and White (Baylor Heart and Vascular)Dallas, TexasUnited States
The Heart Hospital Baylor PlanoPlano, TexasUnited States
Providence Sacred HeartSpokane, WashingtonUnited States
MultiCare Tacoma GeneralTacoma, WashingtonUnited States

+Investigators