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

NCT03583970 | Unknown DMC

• 1 other identifier: PSS2017/LVADECMO-FRITZ/YB
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiogenic Shock; Heart Failure; Extracorporeal Membrane Oxygenation; Left Ventricular Assist Device

Keywords

Left Ventricular Assist Device; Extracorporeal Membrane Oxygenation; Refractory Cardiogenic Shock; Heart Failure; Cardiovascular diseases; Myocardial Infarction; Myocardial Ischemia; Shock

Outcome Measures

Primary Outcomes (1)

• 6-month hospital discharge after LVAD implantation

  6-month hospital discharge after LVAD implantation

  6 month after LVAD implantation

Secondary Outcomes (3)

• Mortality rate

  up to six month after LVAD implantation

• ICU discharge

  up to six month after LVAD implantation

• Quality of life

  up to six month after LVAD implantation

Other Outcomes (10)

• Hemodynamic Failure

  Before LVAD implantation - up to 28 day - up to 6 month

• Cardiogenic failure

  Before LVAD implantation - up to 28 day - up to 6 month

• Cardio-circulatory failure

  Before LVAD implantation - up to 28 day - up to 6 month

Interventions

Left Ventricular Assist Device Implantation DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• ExtraCorporeal Membrane Oxygenation weaving before left ventricular assist device implantation.
• Cardiac assist devices other than Veno-arterial ExtraCorporeal Membrane Oxygenation

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic; Heart Failure; Cardiovascular Diseases; Myocardial Infarction; Myocardial Ischemia; Shock

Condition Hierarchy (Ancestors)

Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Bruno Levy, MD-PhD

  CHRU Nancy

  STUDY CHAIR

Central Study Contacts

Caroline Fritz, MD

CONTACT

+3383157379; fritzcaro@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: July 12, 2018
• Study Start: July 5, 2018
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2020
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

FR (1)