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Evaluation of Predictive Factors for Right Ventriculaire Dysfunction (ECPELLA)

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ClinicalTrials.gov Identifier: NCT04596982
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : January 6, 2022
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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®.

Condition or disease Intervention/treatment
Right Ventriculaire Dysfunction Other: Placement of IMPELLA®

Detailed 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
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Predictive Factors for Right Ventriculaire Dysfunction Post Implantation of Left Mono Ventricular Assistance in Patients in Cardiogenic Shock Under Veno Arterial ECMO
Actual Study Start Date : April 9, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Intervention Details:
  • Other: Placement of IMPELLA®
    ultrasound and hemodynamic parameters of patients in order to establish a predictive score for right-sided dysfunction after placement of IMPELLA®

Outcome Measures
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Primary Outcome Measures :
  1. Absence of right heart failure or failure to withdraw ECMO due to right heart failure after placement of IMPELLA®. [ Time Frame: Within 48 hours of ECMO withdrawal 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.


Secondary Outcome Measures :
  1. Occurrence of severe right heart failure as defined by INTERMACS following implantation of left monoventricular assist [ Time Frame: During all the follow-up 30 days ]

    Association of PVC > 16 mmHg and :

    • Continuation of inotropes or inhaled NO for more than 14 days. or
    • A right circulatory assistance at any time after the implantation of the LVAD or
    • Death related to right heart failure


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  1. - Patient over 18 years of age
  2. - 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.

  3. - 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.

  4. - Patient affiliated or entitled to a French social security system -

Exclusion Criteria:

  1. - SAPS-II Score > 90 (Simplified Acute Physiology Score (SAPS-II) at Inclusion
  2. - Subject deprived of liberty by judicial decision
  3. - Pregnant or breastfeeding woman
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04596982


Contacts
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Contact: LEBRETON Mr Guillaume, PhD 33 1 42 16 29 79 guillaume.lebreton@aphp.fr

Locations
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France
Groupement Hospitalier Pitié-Salpêtrière Recruiting
Paris, France, 75013
Contact: LEBRETON Dr Guillaume, MD, PhD    33 1 42 16 29 79    guillaume.lebreton@aphp.fr   
Contact: HEKIMIAN Guillaume, MD    33 1 42 16 38 28    guillaume.hekimian@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04596982    
Other Study ID Numbers: APHP200528
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: January 6, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
ECMO, Right ventricule failure, Impella, circulatory support