Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Veno-arterial Extracorporeal Membrane Oxygenation Prior to Left Ventricular Assist Device Implantation. (LVAD-ECMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03583970
Recruitment Status : Unknown
Verified July 2018 by Caroline FRITZ, Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
First Posted : July 12, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Caroline FRITZ, Central Hospital, Nancy, France

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment
Cardiogenic Shock Heart Failure Extracorporeal Membrane Oxygenation Left Ventricular Assist Device Device: Left Ventricular Assist Device Implantation

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Veno-arterial Extracorporeal Membrane Oxygenation Support Prior to Left Ventricular Assist Device Implantation : Initial Patients Characteristics and 6 Month Follow-up, a Retrospective Study (2013-2017) (LVAD-ECMO)
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 1, 2020
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Device: 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

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 6-month hospital discharge after LVAD implantation [ Time Frame: 6 month after LVAD implantation ]
    6-month hospital discharge after LVAD implantation


Secondary Outcome Measures :
  1. Mortality rate [ Time Frame: up to six month after LVAD implantation ]
    Six month mortality rate after LVAD implantation

  2. ICU discharge [ Time Frame: up to six month after LVAD implantation ]
    Days until ICU discharge after LVAD implantation

  3. Quality of life [ Time Frame: up to six month after LVAD implantation ]
    ADL and IADL scale


Other Outcome Measures:
  1. Hemodynamic Failure [ Time Frame: Before LVAD implantation - up to 28 day - up to 6 month ]
    Amount of Norepinephrine infused

  2. Cardiogenic failure [ Time Frame: Before LVAD implantation - up to 28 day - up to 6 month ]
    Amount of inotrope infused

  3. Cardio-circulatory failure [ Time Frame: Before LVAD implantation - up to 28 day - up to 6 month ]
    ECLS assistance

  4. Renal failure [ Time Frame: Before LVAD implantation - up to 28 day - up to 6 month ]
    Worst KDIGO stage

  5. Hepatic failure [ Time Frame: Before LVAD implantation - up to 28 day - up to 6 month ]
    Worst values of PT/bilirubin/ AST and ALT

  6. Thrombosis complication [ Time Frame: Before LVAD implantation - up to 28 day - up to 6 month ]
    Thrombosis event

  7. Haemorragic complication [ Time Frame: Before LVAD implantation - up to 28 day - up to 6 month ]
    Haemorragic event

  8. Respiratory failure [ Time Frame: Before LVAD implantation - up to 28 day - up to 6 month ]
    Ventilation assistance

  9. Neurological failure [ Time Frame: Before LVAD implantation - up to 28 day - up to 6 month ]
    neurological sequelae

  10. Infection complication [ Time Frame: Before LVAD implantation - up to 28 day - up to 6 month ]
    documented infection


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients between 01.01.2013 and 31.12.2017 in the participating centers implanted with LVAD during VA-ECMO therapy for refractory cardiogenic shock.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03583970


Contacts
Layout table for location contacts
Contact: Caroline Fritz, MD +3383157379 fritzcaro@gmail.com

Locations
Layout table for location information
France
CHRU Nancy Recruiting
Nancy, France, 54000
Contact: Caroline FRITZ, MD    +33383157379    c.fritz@chru-nancy.fr   
Contact: Bruno LEVY, MD-PhD    +33383154469    b.levy@chru-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Layout table for investigator information
Study Chair: Bruno Levy, MD-PhD CHRU Nancy
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Caroline FRITZ, MD, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03583970    
Other Study ID Numbers: PSS2017/LVADECMO-FRITZ/YB
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Caroline FRITZ, Central Hospital, Nancy, France:
Left Ventricular Assist Device
Extracorporeal Membrane Oxygenation
Refractory Cardiogenic Shock
Heart Failure
 Cardiovascular diseases
Myocardial Infarction
Myocardial Ischemia
Shock
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Shock, Cardiogenic
Heart Diseases
Cardiovascular Diseases
Shock
Pathologic Processes
 Myocardial Infarction
Myocardial Ischemia
Vascular Diseases
Infarction
Ischemia
Necrosis