Actively Recruiting
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
Eligibility Criteria
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
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
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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