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Clinical Trial Summary

An observational study of patients in cardiogenic shock under veno-arterial ECMO is designed to describe the clinical, ultrasound and hemodynamic parameters of these patients and to establish a predictive score for right-sided dysfunction in a patient within 48 hours of ECMO withdrawal after placement of IMPELLA®.


Clinical Trial Description

Therapeutic innovations in the field of heart failure are constant and have improved the prognosis and quality of life of patients. For those suffering from end-stage heart failure, heart transplantation remains the main therapeutic resource, but on the one hand the number of available grafts is insufficient compared to the number of transplant candidates, and on the other hand heart transplantation is accompanied by risks of rejection, infections and cancers, with a current median survival of 12 years . For these reasons, in selected patients, a Left Ventricular Assist Device (LVAD) may be a bridge to transplantation or a way to improve the duration and quality of life of patients without a transplant project (destination therapy). Currently, about half of all heart transplants performed internationally are done in patients with left monoventricular assist, and in 2017 43% of implanted LVAD patients were in destination therapy. For this reason, this observational study aims to describe the clinical, ultrasound and hemodynamic parameters of these patients and to establish a predictive score for right-sided dysfunction in a patient during the 30-day follow-up. More precisely, during this study we will compare the clinical, ultrasound and hemodynamic parameters of these patients in order to establish a predictive score for right-sided dysfunction during : - 48 hours on ECMO and IMPELLA (after IMPELLA® placement) - 48 hours on IMPELLA alone following ECMO withdrawal. - 48 hours under left monoventricular assistance - At day 7 of the follow-up - At day30 of the follow-up Patients who develop right heart failure within 48 hours of ECMO withdrawal after IMPELLA® placement will be compared to patients without right heart failure on demographic, clinical, history, treatment history, and cardiac echo and hemodynamic data at admission. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04596982
Study type Observational
Source Assistance Publique - Hôpitaux de Paris
Contact LEBRETON Mr Guillaume, PhD
Phone 33 1 42 16 29 79
Email guillaume.lebreton@aphp.fr
Status Recruiting
Phase
Start date April 9, 2021
Completion date March 2023