Actively Recruiting
Early Preventive Left Ventricle Unloading After VA-ECMO for Refractory Cardiogenic Shock
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-04-13
298
Participants Needed
12
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of early preventive left ventricle unloading using an intra-aortic balloon pump (IABP) in patients receiving venoarterial extracorporeal membrane oxygenation (VA-ECMO) for severe cardiogenic shock. Cardiogenic shock often results from conditions like acute myocardial infarction or end-stage heart failure, and VA-ECMO is used to support heart function. However, VA-ECMO can increase left ventricular afterload, potentially worsening outcomes by causing complications such as pulmonary congestion and delaying heart recovery or transplantation. Previous studies have produced mixed results, highlighting the need for a well-powered trial to assess early unloading benefits compared to conventional care.
CONDITIONS
Brief Title
Early Preventive Left Ventricle Unloading After VA-ECMO for Refractory Cardiogenic Shock
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient on peripheral femoro-femoral VA ECMO for severe cardiogenic shock for 24 hours or less
- Initiation of left ventricle unloading possible within 12 hours after randomization
- Consent obtained from a close relative or surrogate, or emergency consent with later patient consent when possible
- Registered with social security (AME excluded)
You will not qualify if you...
- Age under 18 years
- Pregnancy
- VA-ECMO started more than 24 hours before
- Overt pulmonary edema requiring urgent unloading despite optimized management
- ECMO for massive pulmonary embolism or primary right ventricular failure
- ECMO after heart transplant
- ECMO after left ventricular assist device surgery
- Resuscitation longer than 30 minutes before ECMO unless fully conscious at randomization
- ECMO for refractory cardiac arrest (E-CPR)
- Grade 3-4 aortic regurgitation
- Mechanical complications of acute myocardial infarction (massive mitral regurgitation, pericardial drainage, septal ventricular defect)
- Patient moribund on day of randomization
- Cerebral deficit with fixed dilated pupils or irreversible neurological pathology
- Severe concomitant disease with life expectancy under 1 year
- Existing durable ventricular assist device, IABP, or other temporary mechanical support before enrollment
- Severe peripheral artery disease or prior aortic/ilio-femoral surgery preventing IABP or Impella insertion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants must be on peripheral femoro-femoral VA ECMO for severe cardiogenic shock for 24 hours or less and meet other criteria before enrollment.
Duration - Up to 30 days post-randomization
Participants receive early left ventricle unloading with an intra-aortic balloon pump inserted as soon as possible, within 12 hours post-randomization. Hemodynamic monitoring with a pulmonary artery catheter and daily Doppler echocardiography are performed. Escalations to additional unloading procedures may occur if needed.
Continuous monitoring with daily Doppler echocardiography and ongoing clinical assessments during hospitalization.
Duration - Up to 60 days post-randomization
Participants are monitored for outcomes including mortality, complications related to unloading devices, duration of mechanical support, and hospital stay up to 60 days after randomization.
Periodic assessments up to Day 60 to track recovery and complications.
Trial Site Locations
Total: 12 locations
1
CHU Clermont-Ferrand - Site Gabriel Montpied
Clermont-Ferrand, France, 63000
Not Yet Recruiting
2
Henri Mondor
Créteil, France, 94000
Not Yet Recruiting
3
Hôpital Cardiologique
Lille, France, 59000
Not Yet Recruiting
4
APHP - hôpital Pitié-Salpêtrière
Paris, France, 75013
Actively Recruiting
5
APHP - hôpital Pitié-Salpêtrière
Paris, France, 75013
Not Yet Recruiting
6
APHP - hôpital Pitié-Salpêtrière
Paris, France, 75013
Not Yet Recruiting
7
Hôpital Européen Georges Pompidou
Paris, France, 75015
Not Yet Recruiting
8
Hôpital du Pontchaillou
Rennes, France, 35033
Not Yet Recruiting
9
Nouvel Hôpital Civil
Strasbourg, France, 67000
Not Yet Recruiting
10
Nouvel hôpital civil
Strasbourg, France, 67000
Not Yet Recruiting
11
Hôpital Rangueil
Toulouse, France, 31059
Not Yet Recruiting
12
CHRU Nancy - hôpitaux de brabois
Vandœuvre-lès-Nancy, France, 54500
Not Yet Recruiting
Research Team
A
Alain COMBES, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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