Early preventive left ventricle unloading after peripheral VA-ECMO for refractory cardiogenic shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional trial enrolls adult patients who have been started on peripheral femoro-femoral VA-ECMO within the previous 24 hours and randomizes them to early left ventricular unloading or standard care. The unloading procedure must be initiated within 12 hours after randomization and is intended to prevent left ventricular distension, aortic valve closure, and pulmonary congestion associated with VA-ECMO. Investigators will track clinical outcomes such as pulmonary edema, need for mechanical ventilation, markers of myocardial recovery, and survival. Consent is obtained from a surrogate when needed and patients are treated at participating French centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient on peripheral femoro-femoral VA ECMO for severe Cardiogenic shock for ≤24h
2. Initiation of LV unloading possible within 12 hours after randomization.
3. Consent obtained from a close relative or surrogate. Should such a person be absent, eligible patients will be randomized according to the specifications of emergency consent and the patient will be asked to give his/her consent for the continuation of the trial when his/her condition will allow.
4. Social security registration (AME excluded)

Exclusion Criteria:

1. Age \<18 years
2. Pregnancy
3. Onset of VA-ECMO \>24 h
4. Overt pulmonary edema despite optimization of patient's management (titration of ECMO blood flow, inotropes, non-invasive mechanical ventilation with PEEP, diuretics or hemofiltration) requiring urgent LV unloading
5. ECMO for massive pulmonary embolism or primary RV failure
6. ECMO after heart transplant
7. ECMO after LVAD surgery
8. Resuscitation \>30 minutes before ECMO (cumulative low-flow time), except if the patient has fully recover consciousness at the time of randomization.
9. ECMO for refractory cardiac arrest (E-CPR)
10. Grade 3-4 aortic regurgitation
11. Mechanical complication of acute myocardial infarction (massive mitral regurgitation, pericardium drainage required, septal ventricular defect)
12. Patient moribund on the day of randomization
13. Cerebral deficit with fixed dilated pupils or Irreversible neurological pathology
14. Other severe concomitant disease with limited life expectancy \<1 year
15. Patient has a durable ventricular assist device, an IABP or another temporary mechanical circulatory support (other than ECMO) prior to enrollment.
16. Severe peripheral artery disease or previous aortic or ilio-femoral surgery precluding IABP or IMPELLA insertion.

Where it's running

• APHP - hôpital Pitié-Salpêtrière
  Paris, France Recruiting
• CHU Clermont-Ferrand - Site Gabriel Montpied
  Clermont-Ferrand, France Not yet recruiting
• Henri Mondor
  Créteil, France Not yet recruiting
• Hôpital Cardiologique
  Lille, France Not yet recruiting
• APHP - hôpital Pitié-Salpêtrière
  Paris, France Not yet recruiting
• APHP - hôpital Pitié-Salpêtrière
  Paris, France Not yet recruiting

Study contacts

• Study coordinator: Alain COMBES, MD
• Email: alain.combes@aphp.fr
• Phone: 0142163818

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Outcomes in patients with mixed cardiogenic and vasoplegic shock

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  Recruiting Centre Hospitalier Universitaire, Amiens · Amiens, Somme · NCT07354568

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.