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

Early Preventive Left Ventricle Unloading After VA-ECMO for Refractory Cardiogenic Shock

This study will try early left ventricular unloading in adults on peripheral VA-ECMO for severe cardiogenic shock to see if it reduces lung congestion and helps the heart recover.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 298 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 12 sites (Clermont-Ferrand and 11 other locations)
• Trial ID: NCT07027202 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults on peripheral femoro-femoral VA-ECMO for severe cardiogenic shock started ≤24 hours earlier who can receive LV unloading within 12 hours and for whom consent or surrogate consent can be obtained are eligible.

Not a fit: Patients unlikely to benefit include those with overt pulmonary edema requiring urgent unloading, primary right ventricular failure or massive pulmonary embolism, those on ECMO after heart transplant or LVAD surgery, pregnant patients, and children under 18.

Why it matters

Potential benefit: If successful, early LV unloading could reduce pulmonary congestion, shorten the need for mechanical ventilation, and improve myocardial recovery and survival.

How similar studies have performed: Observational studies and device registries have suggested benefit from early LV unloading during VA-ECMO, but high-quality randomized evidence is limited.

Eligibility criteria

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 this trial is running

Clermont-Ferrand and 11 other locations

• 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 (Recruiting)
• APHP - hôpital Pitié-Salpêtrière — Paris, France (Not_yet_recruiting)
• APHP - hôpital Pitié-Salpêtrière — Paris, France (Not_yet_recruiting)
• Hôpital Européen Georges Pompidou — Paris, France (Not_yet_recruiting)
• Hôpital du Pontchaillou — Rennes, France (Not_yet_recruiting)
• Nouvel Hôpital Civil — Strasbourg, France (Not_yet_recruiting)
• Nouvel hôpital civil — Strasbourg, France (Not_yet_recruiting)
• Hôpital Rangueil — Toulouse, France (Not_yet_recruiting)
• CHRU Nancy - hôpitaux de brabois — Vandœuvre-lès-Nancy, France (Not_yet_recruiting)

Study contacts

• Study coordinator: Alain COMBES, MD

Conditions Cardiogenic Shock Acute; ECMO; BPIA; Cardiogenic shock acute