Evaluation of Predictive Factors for Right Ventriculaire Dysfunction

NCT04596982 | Completed

• 1 other identifier: APHP200528
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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®.

Conditions

Right Ventriculaire Dysfunction

Keywords

ECMO, Right ventricule failure, Impella, circulatory support

Outcome Measures

Primary Outcomes (1)

• Absence of right heart failure or failure to withdraw ECMO due to right heart failure after placement of IMPELLA®.

  The definition of right heart failure as defined by the INTERMACS takes into account the evolution of hemodynamic parameters during the 14 days following the implantation of the left monoventricular assist and is therefore not adapted to the situation of patients on veno-arterial ECMO who are going to have an IMPELLA for the purpose of ECMO weaning.

  Within 48 hours of ECMO withdrawal after placement of IMPELLA®

Secondary Outcomes (1)

• Occurrence of severe right heart failure as defined by INTERMACS following implantation of left monoventricular assist

  During all the follow-up 30 days

Interventions

Placement of IMPELLA® OTHER

ultrasound and hemodynamic parameters of patients in order to establish a predictive score for right-sided dysfunction after placement of IMPELLA®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult patients consecutively admitted to the cardiac medical and surgical intensive care units having : venoartrial ECMO and in whom the implantation of an assistance by IMPELLA is decided while waiting for the implantation of a left monoventricular assistance

You may qualify if:

• \- Patient over 18 years of age
• \- Patient under ECMO hospitalized in the medical intensive care unit or the surgical intensive care unit of the Groupement hospitalier Pitié-Salpêtrière, not weaned from ECMO, in whom it was decided at the multidisciplinary collegial meeting on assistance-transplantation to set up an IMPELLA before the implantation of left monoventricular assistance.
• \- Patient who received informed information about the study and did not express opposition to participation in the research.
• Special Cases :
• o For patients who are unable to express their non-opposition, the investigator may request that of a relative of the patient.
• or For patients under guardianship, their non opposition must be obtained in the presence of the guardian.
• or For patients under guardianship, it is the legal guardian's non opposition that will be requested.
• The modalities of information and obtaining the non opposition will be reported in the patient's medical file.
• \- Patient affiliated or entitled to a French social security system -

You may not qualify if:

• \- Subject deprived of liberty by judicial decision
• \- Pregnant or breastfeeding woman

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Groupement Hospitalier Pitié-Salpêtrière

Paris, 75013, France

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 22, 2020
• Study Start: April 9, 2021
• Primary Completion: October 25, 2023
• Study Completion: October 25, 2023
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)