Actively Recruiting

Age: 1Day - 80Years
All Genders
ID06766006

A Multicenter Study Comparing Left Ventricular Unloading Methods During Veno-Arterial Extracorporeal Life Support in Patients with Cardiogenic Shock or Cardiac Arrest

Led by Maastricht University Medical Center · Updated on 2025-01-09

500

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

M

Maastricht University Medical Center

Lead Sponsor

I

IRCCS Policlinico S. Donato

Collaborating Sponsor

AI-Summary

What this Trial Is About

This international multicenter prospective observational study focuses on patients receiving veno-arterial extracorporeal life support (VA ECLS) for cardiogenic shock or cardiac arrest, conditions with very high hospital mortality rates. The research aims to understand left ventricular (LV) overload during VA ECLS and to describe and compare various LV unloading strategies in a large global patient group. The study also seeks to establish a shared definition of LV overload by collecting clinical, hemodynamic, and radiological data before and after unloading. Participants will undergo VA ECLS implantation as part of standard care for refractory cardiogenic shock or cardiac arrest. The study observes the use of different LV unloading techniques, collecting detailed information about when and how these strategies are applied. There are no additional interventions beyond the standard treatment necessary for patient care. During the study, researchers will gather demographic, clinical, instrumental, and laboratory data before and after VA ECLS implantation. They will monitor outcomes such as in-hospital mortality at 30 days and assess echocardiographic parameters related to LV overload and unloading effectiveness within 12 hours before and after the unloading technique. The study tracks patient progress to better understand the efficacy and impact of various LV unloading methods under real-world conditions.

CONDITIONS

Official Title

ECMO LEft Ventricle UNloading Strategy

Who Can Participate

Age: 1Day - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All patients undergoing VA ECLS will be enrolled.
Not Eligible

You will not qualify if you...

  • Patients without VA ECMO will not be considered

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Trial Site Locations

Total: 1 location

1

Maastricht UMC

Maastricht, Netherlands

Actively Recruiting

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Research Team

P

Paolo Meani, MD, PhD

R

Roberto Lorusso, MD,PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Left Ventricular Unloading Is Associated With Lower Mortality in Patients With Cardiogenic Shock Treated With Venoarterial Extracorporeal Membrane Oxygenation: Results From an International, Multicenter Cohort Study.

Benedikt Schrage, Peter Moritz Becher, Alexander Bernhardt...

https://pubmed.ncbi.nlm.nih.gov/33032450

A 5-year experience with cardiopulmonary resuscitation using extracorporeal life support in non-postcardiotomy patients with cardiac arrest.

Assad Haneya, Alois Philipp, Claudius Diez...

https://pubmed.ncbi.nlm.nih.gov/22819880

Left ventricular unloading during veno-arterial ECMO: a review of percutaneous and surgical unloading interventions.

Dirk W Donker, Daniel Brodie, José P S Henriques...

https://pubmed.ncbi.nlm.nih.gov/30112975

Modalities and Effects of Left Ventricle Unloading on Extracorporeal Life support: a Review of the Current Literature.

Paolo Meani, Sandro Gelsomino, Eshan Natour...

https://pubmed.ncbi.nlm.nih.gov/28470925

Protracted aortic valve closure during peripheral veno-arterial extracorporeal life support: is intra-aortic balloon pump an effective solution?

Paolo Meani, Thijs Delnoij, Giuseppe M Raffa...

https://pubmed.ncbi.nlm.nih.gov/30024298

Simultaneous Venoarterial Extracorporeal Membrane Oxygenation and Percutaneous Left Ventricular Decompression Therapy with Impella Is Associated with Improved Outcomes in Refractory Cardiogenic Shock.

Sandeep M Patel, Jerry Lipinski, Sadeer G Al-Kindi...

https://pubmed.ncbi.nlm.nih.gov/29489461