Veno-arterial Extracorporeal Membrane Oxygenation Prior to Left Ventricular Assist Device Implantation.

NCT ID: NCT03583970

Last Updated: 2018-07-17

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

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-05

Study Completion Date

2020-12-01

Brief Summary

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Cardiogenic shock is an uncommun pathology with a high mortatily rate around 45%. Veno arterial extracorporeal membrane oxygenation (VA-ECMO) is a temporary extracorporeal assist device which restore an adequate blood flow when a circulatory failure occures. VA-ECMO main indication is refractory cardiogenic shock whatever the etiology. Current medical care of terminal cardiac failure includes use of long-term mechanical circulatory support devices (MCSD) such as Left Ventricular Assist Device (LVAD). LVAD therapy may lead to heart transplant (bridge to transplantation), to recovery (bridge to recovery) or to permanent implantation (destination therapy). Few patients with refractory cardiogenic shock treated with VA-ECMO may secondarily need a long term MCSD with LVAD.

LVAD long-term heart assist showed interesting survival rate when implantation occured (71% after 2 years follow-up and 45% after 4 years follow-up) out of acute heart failure situation. There are only few datas concerning LVAD implantion during refractory cardiogenic shock, with a mortality between 20 to 50% in different studies.

In this way, in comparaison of current few datas on the subject of LVAD implantation under VA-ECMO, the investigators (15 french-speacking centers) would retrospectively describe a large population.

Detailed Description

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Conditions

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Cardiogenic Shock Heart Failure Extracorporeal Membrane Oxygenation Left Ventricular Assist Device

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Left Ventricular Assist Device Implantation

Veno-arterial extracorporeal membrane oxygenation prior to left ventricular assist device implantation : initial patients characteristics and 6 Month Follow-up

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Veno-arterial ExtraCorporeal Membrane Oxygenation prior to left ventricular assist device implantation.
* Veno-arterial ExtraCorporeal Membrane Oxygenation at the left ventricular assist device implantation operative time

Exclusion Criteria

* ExtraCorporeal Membrane Oxygenation weaving before left ventricular assist device implantation.
* Cardiac assist devices other than Veno-arterial ExtraCorporeal Membrane Oxygenation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Caroline FRITZ

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruno Levy, MD-PhD

Role: STUDY_CHAIR

CHRU Nancy

Locations

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CHRU Nancy

Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Caroline Fritz, MD

Role: CONTACT

+3383157379

Facility Contacts

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Caroline FRITZ, MD

Role: primary

+33383157379

Bruno LEVY, MD-PhD

Role: backup

+33383154469

Other Identifiers

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PSS2017/LVADECMO-FRITZ/YB

Identifier Type: -

Identifier Source: org_study_id

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