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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03583970
Other study ID # PSS2017/LVADECMO-FRITZ/YB
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 5, 2018
Est. completion date December 1, 2020

Study information

Verified date July 2018
Source Central Hospital, Nancy, France
Contact Caroline Fritz, MD
Phone +3383157379
Email fritzcaro@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 1, 2020
Est. primary completion date June 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France CHRU Nancy Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Hemodynamic Failure Amount of Norepinephrine infused Before LVAD implantation - up to 28 day - up to 6 month
Other Cardiogenic failure Amount of inotrope infused Before LVAD implantation - up to 28 day - up to 6 month
Other Cardio-circulatory failure ECLS assistance Before LVAD implantation - up to 28 day - up to 6 month
Other Renal failure Worst KDIGO stage Before LVAD implantation - up to 28 day - up to 6 month
Other Hepatic failure Worst values of PT/bilirubin/ AST and ALT Before LVAD implantation - up to 28 day - up to 6 month
Other Thrombosis complication Thrombosis event Before LVAD implantation - up to 28 day - up to 6 month
Other Haemorragic complication Haemorragic event Before LVAD implantation - up to 28 day - up to 6 month
Other Respiratory failure Ventilation assistance Before LVAD implantation - up to 28 day - up to 6 month
Other Neurological failure neurological sequelae Before LVAD implantation - up to 28 day - up to 6 month
Other Infection complication documented infection Before LVAD implantation - up to 28 day - up to 6 month
Primary 6-month hospital discharge after LVAD implantation 6-month hospital discharge after LVAD implantation 6 month after LVAD implantation
Secondary Mortality rate Six month mortality rate after LVAD implantation up to six month after LVAD implantation
Secondary ICU discharge Days until ICU discharge after LVAD implantation up to six month after LVAD implantation
Secondary Quality of life ADL and IADL scale up to six month after LVAD implantation
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