IMPELLA, Complications and Tolerance

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients admitted for cardiogenic shock supported by Impella (5, 5.5 or CP) between January 1, 2010, and December 31, 2022 (as an isolated circulatory support or combined with others Temporary Mechanical Circulatory Support)

Locations
Other Locations
France
Montpellier university hospital
RECRUITING
Montpellier
Contact Information
Primary
Aurore UGHETTO, MD
a-ughetto@chu-montpellier.fr
+33622054893
Backup
Clément DELMAS, MD, PhD
clement23185@hotmail.fr
+330673147951
Time Frame
Start Date: 2010-01-01
Estimated Completion Date: 2025-01-30
Participants
Target number of participants: 800
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov