Impella Real-World Surveillance of Patients Using Sodium Bicarbonate

NCT05820451 | Completed FDA Device

• 1 other identifier: ABMD-CIP-21-02-SS01
• Study Type: observational
• Target: 312
• Locations: 1 country
• Sites: 20

Brief Summary

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

Conditions

Cardiogenic Shock; High Risk PCI

Outcome Measures

Primary Outcomes (2)

• Primary Endpoint Left Sided Impella

  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

  Rate of heiarchical composite of pulmonary thromboemboli and deep vein thrombosis (DVT)

  From hospital admission until hospital discharge, average 5 days

Study Arms (2)

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

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

Interventions

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.

Left sided device

Impella RP with Sodium Bicarbonate used as purge solution DEVICE

US commercially approved Abiomed right sided hemodynamic support devices (Impella) will be included.

Right sided device

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Left-sided Impella with bicarbonate in the purge

You may not qualify if:

• Known LV thrombus
• Right Sided Impella
• Right-sided Impella with bicarbonate in the purge
• Known pulmonary thromboemboli
• Known DVT

Sponsors & Collaborators

• Abiomed Inc.: lead

Study Sites (20)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

Pima Heart and Vascular (Tuscon Medical Center)

Tucson, Arizona, 85712, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Keck USC Medical Center

Los Angeles, California, 90033, United States

Location

Advent Helath Orlando

Orlando, Florida, 32804, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Henry Ford

Detroit, Michigan, 48202, United States

Location

Ascension St. John Hospital

Detroit, Michigan, 48236, United States

Location

Providence St. Patrick

Missoula, Montana, 59802, United States

Location

University of Nebraska

Omaha, Nebraska, 68105, United States

Location

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Christ Hospital

Cincinnatti, Ohio, 45219, United States

Location

Montefiore Medical Center - Moses

Portland, Oregon, 97205, United States

Location

Legacy Emanuel

Portland, Oregon, 97227, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Baylor Scott and White (Baylor Heart and Vascular)

Dallas, Texas, 75226, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Providence Sacred Heart

Spokane, Washington, 99204, United States

Location

MultiCare Tacoma General

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Amin Medjamia, MD

  Abiomed Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 19, 2023
• Study Start: December 15, 2022
• Primary Completion: February 22, 2024
• Study Completion: February 22, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)