ECMELLA vs. ECMO on 30-day Mortality

Acute Myocardial Infarction Clinical Trial

Official title:

Treatment With Leftventricular Impella® Micro-axial Pump and Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO) During Extracorporeal Cardiopulmonary Resuscitation (eCPR) on Mortality - An International Multicenter Cohort Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05175898
• Other study ID #: ECMELLA vs. ECMO
• Status: Enrolling by invitation
• Start date: February 2022
• Est. completion date: November 2022

Study information

• Verified date: December 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This international, multicenter cohort study aims to investigate outcomes after treatment with extracorporeal cardiopulmonary resuscitation (eCPR) during cardiac arrest.

Description:

Left ventricular unloading with Impella® micro-axial pump has been shown to improve survival in patients with cardiogenic shock treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO). This study aims to investigate whether treatment with VA-ECMO and Impella ® (so called "ECMELLA") during extracorporeal cardiopulmonary resuscitation is associated with improved outcomes.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: November 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients
• Cardiac arrest
• Treatment with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or "ECMELLA" (that is VA-ECMO plus left ventricular Impella® micro-axial pump)

Exclusion Criteria:

• Non-adult patients
• No treatment with VA-ECMO or "ECMELLA"

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Cardiac Arrest
• Cardiogenic Shock
• Cardiopulmonary Arrest
• Extracorporeal Membrane Oxygenation Complication
• Heart Arrest
• Infarction
• Myocardial Infarction
• Shock, Cardiogenic

Intervention

Device:
• VA-ECMO
Treatment with veno-arterial extracorporeal membrane oxygenation
• ECMELLA
Treatment with veno-arterial extracorporeal membrane oxygenation plus Impella® micro-axial pump.

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality	Mortality within 30 days after cardiac arrest event.	Mortality within 30 days after cardiac arrest event.
Secondary	Hospital length of stay	Number of days between hospital admission and hospital discharge.	Through study completion - an average of 1 year.
Secondary	Intensive Care Unit (ICU) length of stay	Number of ICU days between ICU admission and ICU discharge.	Through study completion - an average of 1 year.