ECLS Versus IMPELLA™ as Bridge to LVAD (ECI-BLAD)

NCT ID: NCT04480151

Last Updated: 2021-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-20

Study Completion Date

2021-04-21

Brief Summary

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In this retrospective observational multicenter study the authors tested the hypothesis that the use of IMPELLA™ pump as bridge to bridge, by giving the opportunity of active rehabilitation, should improve patient's outcomes after the implantation of Left Ventricular Assist Device (LVAD).

Detailed Description

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End stage heart failure patients admitted in Intensive Care Unit (ICU) for refractory cardiogenic shock requiring short-term mechanical circulatory support as a bridge to a long-term LVAD might benefit from early mobilization and rehabilitation with IMPELLA™ inserted via the axillary artery. The aim of this study is to compare the early rehabilitation and outcomes after LVAD implantation between patients previously treated by IMPELLA™ or ExtraCorporeal Life Support (ECLS)

Conditions

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Cardiogenic Shock End-stage Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IMPELLA™ alone as bridge to LVAD

patients assisted by IMPELLA™ pump alone during the days preceding the implantation of long term LVAD (at least 48 hours for patients for whom an ECLS was previously used)

standard of care

Intervention Type OTHER

retrospective study: standard of care

ECLS alone or with IMPELLA™ as bridge to LVAD

patients assisted by ECLS (ExtraCorporeal life support) alone or simultaneously with IMPELLA™ until the implantation of LVAD

standard of care

Intervention Type OTHER

retrospective study: standard of care

Interventions

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standard of care

retrospective study: standard of care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients supported with IMPELLA™ or ECLS for refractory cardiogenic shock as a bridge to long duration LVAD

Exclusion Criteria

* Patient refusing to give access to their medical chart
* Guardianship and curactorship
* Deprived of liberty
* short term mechanical circulatory system weaned before LVAD implantation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandre OUATTARA, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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CHU de Dijon-Bourgoigne

Dijon, , France

Site Status

CHU de Montpellier

Montpellier, , France

Site Status

CHU de Bordeaux

Pessac, , France

Site Status

CHU de Rennes

Rennes, , France

Site Status

CHU de Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2020/37

Identifier Type: -

Identifier Source: org_study_id

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