Clinical trial NCT05820451: Impella Real-World Surveillance of Patients Using Sodium Bicarbonate
Official title: Impella Real-World Surveillance of Patients Using Sodium Bicarbonate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiogenic Shock
High Risk PCI
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-19
Enrollment: 312
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects who received an Impella in which a bicarbonate-based purge solution was used

Brief 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: 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

Primary outcomes:
measure: Primary Endpoint Left Sided Impella
timeFrame: From hospital admission until hospital discharge, average 5 days
measure: Primary Endpoint Right Sided Impella
timeFrame: From hospital admission until hospital discharge, average 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Tucson
country: United States
facility: Pima Heart and Vascular (Tuscon Medical Center)
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: Keck USC Medical Center
state: California
city: Orlando
country: United States
facility: Advent Helath Orlando
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Detroit
country: United States
facility: Henry Ford
state: Michigan
city: Detroit
country: United States
facility: Ascension St. John Hospital
state: Michigan
city: Missoula
country: United States
facility: Providence St. Patrick
state: Montana
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: Cincinnatti
country: United States
facility: Christ Hospital
state: Ohio
city: Portland
country: United States
facility: Montefiore Medical Center - Moses
state: Oregon
city: Portland
country: United States
facility: Legacy Emanuel
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor Scott and White (Baylor Heart and Vascular)
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Spokane
country: United States
facility: Providence Sacred Heart
state: Washington
city: Tacoma
country: United States
facility: MultiCare Tacoma General
state: Washington
Study officials:
affiliation: Abiomed Inc.
name: Amin Medjamia, MD
role: STUDY_DIRECTOR
References: