Actively Recruiting

Age: 18Years +
All Genders
NCT06644963

IMPELLA, Complications and Tolerance

Led by University Hospital, Montpellier · Updated on 2024-10-16

800

Participants Needed

1

Research Sites

786 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Myocardial infarction complicated by cardiogenic shock (AMICS) is associated with high morbidity and mortality, and devices like Impella® CP and Impella 5.0-5.5 are often used for hemodynamic support, either alone or combined with veno-arterial ECMO (ECMELLA). While recent studies suggest improved survival with Impella® in cardiogenic shock, complications remain common, particularly due to deep arterial access and the need for anticoagulation. Hemocompatibility-related adverse events (HRAEs) such as ischemia, bleeding (44%), hemolysis (32%), and stroke (13%) frequently occur. Achieving hemocompatibility between the patient's blood and the device is challenging, as pump flow, anticoagulation, and patient factors contribute to both thrombotic and hemorrhagic complications. Despite advances, further research is required to better understand and reduce these risks in clinical practice.

CONDITIONS

Official Title

IMPELLA, Complications and Tolerance

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults admitted for cardiogenic shock supported by Impella (5, 5.5, or CP) between January 1, 2010, and December 31, 2022
  • Use of Impella as isolated circulatory support or combined with other temporary mechanical circulatory support
Not Eligible

You will not qualify if you...

  • No use of Impella device
  • Use of Impella 2.5 model
  • Use of Impella RP (right) device

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Montpellier university hospital

Montpellier, France, 34295

Actively Recruiting

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Research Team

A

Aurore UGHETTO, MD

CONTACT

C

Clément DELMAS, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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