ECPella: Concept, Physiology and Clinical Applications.
P Meani, R Lorusso, F Pappalardo
https://pubmed.ncbi.nlm.nih.gov/33642170/Actively Recruiting
Led by Maastricht University Medical Center · Updated on 2025-01-09
500
Participants Needed
1
Research Sites
N/A
Total Duration
This research aims to collect and analyze clinical data from patients receiving veno-arterial extracorporeal life support VA ECLS in intensive care units worldwide. It focuses on understanding left ventricular LV overload and comparing different methods to unload the LV during VA ECLS. The study addresses the serious conditions of cardiogenic shock and cardiac arrest, which have high mortality rates, and aims to clarify the best strategies for LV unloading to support heart function recovery. The study observes patients who have undergone implantation of VA ECLS, a procedure that supports heart and lung function by circulating blood outside the body. Researchers will document and compare various LV unloading techniques used in standard care across multiple centers, without adding extra interventions. Data on timing, types, and methods of unloading will be collected, along with clinical and radiological information before and after unloading. Participants demographic, clinical, instrumental, and laboratory data will be gathered before and after VA ECLS implantation. Researchers will assess outcomes such as in-hospital mortality at 30 days, echocardiographic measures of LV overload and unloading effectiveness, major adverse events, LV function, and neurological status at discharge. The study is prospective and observational, with no additional treatments beyond usual care, and will follow patients up to 30 days after the procedure.
CONDITIONS
ECMO LEft Ventricle UNloading Strategy
P
Paolo Meani, MD, PhD
R
Roberto Lorusso, MD,PhD
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Maastricht University Medical Center
Lead Sponsor
IRCCS Policlinico S. Donato
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of VA ECLS support as per clinical need
Participants undergo implantation of venoarterial extracorporeal life support (VA ECLS) as part of routine care for refractory cardiogenic shock or cardiac arrest.
Data collected before and after VA ECLS implantation according to standard care
Duration - Up to 30 days after implantation
Participants are observed to assess left ventricular unloading strategies, clinical outcomes, and recovery during and after VA ECLS treatment.
Assessments within 12 hours before and 12 hours after unloading technique and follow-up at Day 30
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Lead Sponsor
IRCCS Policlinico S. Donato
Collaborating Sponsor