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RECRUITING
NCT06644963

IMPELLA, Complications and Tolerance

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

800

Start Date

2010-01-01

Completion Date

2025-01-30

Last Updated

2024-10-16

Healthy Volunteers

No

Interventions

DEVICE

Impella (5, 5.5 or CP)

Impella (5, 5.5 or CP) as an isolated circulatory support or combined with others Temporary Mechanical Circulatory Support

Locations (1)

Montpellier university hospital

Montpellier, France