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Impella Real-World Surveillance of Patients Using Sodium Bicarbonate

NCT05820451 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 312

Last updated 2024-09-04

No results posted yet for this study

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

Interventions

DEVICE

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.

DEVICE

Impella RP with Sodium Bicarbonate used as purge solution

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

Sponsors & Collaborators

  • Abiomed Inc.

    lead INDUSTRY

Principal Investigators

  • Amin Medjamia, MD · Abiomed Inc.

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2024-02-22
Completion
2024-02-22
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05820451 on ClinicalTrials.gov