Cardiogenic Shock AcuteEULODIANCT07027202
Early Preventive Left Ventricle Unloading After VA-ECMO for Refractory Cardiogenic Shock
A study testing Early Left Ventricle unloading in people with Cardiogenic Shock Acute, run by Assistance Publique - Hôpitaux de Paris at 12 sites in France.
Trial summary
Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly being used worldwide to treat severe cardiogenic shock. The survival rate of these patients has increased in the last decade, reaching 45-50% for patients with acute myocardial infarction (AMI), the most frequent indication of the technique… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock Acute
- What is being tested?
- Early Left Ventricle unloading
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 12 sitesFrance
- Study dates
- 13 Mar 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient on peripheral femoro-femoral VA ECMO for severe Cardiogenic shock for ≤24h
- Initiation of LV unloading possible within 12 hours after randomization.
- 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.
- Social security registration (AME excluded)
Who cannot join
- Age <18 years
- Pregnancy
- Onset of VA-ECMO >24 h
- 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
- ECMO for massive pulmonary embolism or primary RV failure
- ECMO after heart transplant
Show all 16Show fewer
- ECMO after LVAD surgery
- Resuscitation >30 minutes before ECMO (cumulative low-flow time), except if the patient has fully recover consciousness at the time of randomization.
- ECMO for refractory cardiac arrest (E-CPR)
- Grade 3-4 aortic regurgitation
- Mechanical complication of acute myocardial infarction (massive mitral regurgitation, pericardium drainage required, septal ventricular defect)
- Patient moribund on the day of randomization
- Cerebral deficit with fixed dilated pupils or Irreversible neurological pathology
- Other severe concomitant disease with limited life expectancy <1 year
- Patient has a durable ventricular assist device, an IABP or another temporary mechanical circulatory support (other than ECMO) prior to enrollment.
- Severe peripheral artery disease or previous aortic or ilio-femoral surgery precluding IABP or IMPELLA insertion.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
France12 sites, 12 recruiting
- Not yet recruiting
CHU Clermont-Ferrand - Site Gabriel Montpied
Clermont-Ferrand, 63000
Nicolas D'OSTREVY, MD, +33473750750, ndostrevy@chu-clermontferrand.fr
- Not yet recruiting
Henri Mondor
Créteil, 94000
Nicolas MONGARDON, MD, +33145136417, nicolas.mongardon@aphp.fr
- Not yet recruiting
Hôpital Cardiologique
Lille, 59000
Marie JUNGLING, MD, +33320445442, marie.jungling@chu-lille.fr
- Recruiting
APHP - hôpital Pitié-Salpêtrière
Paris, 75013
Alain COMBES, MD, +33142163818, alain.combes@aphp.fr
- Not yet recruiting
APHP - hôpital Pitié-Salpêtrière
Paris, 75013
Adrien BOUGLE, MD, +33142162991, adrien.bougle@aphp.fr
- Not yet recruiting
APHP - hôpital Pitié-Salpêtrière
Paris, 75013
Guillaume LEBRETON, MD, +33142163092, guillaume.lebreton@aphp.fr
- Not yet recruiting
Hôpital Européen Georges Pompidou
Paris, 75015
Simon MESLIN, MD, +33156092061, simon.meslin@aphp.fr
- Not yet recruiting
Hôpital du Pontchaillou
Rennes, 35033
Nicolas NESSELER, +33299284321, nicolas.nesseler@chu-rennes.fr
- Not yet recruiting
Nouvel Hôpital Civil
Strasbourg, 67000
Michel KINDO, MD, +33369550811, michel.kindo@chru-strasbourg.fr
- Not yet recruiting
Nouvel hôpital civil
Strasbourg, 67000
Hamid MERDJI, MD, +33369551123, hamid.merdji@chru-strasbourg.fr
- Not yet recruiting
Hôpital Rangueil
Toulouse, 31059
Fanny VARDON, MD, +33561322799, vardon.f@chu-toulouse.fr
- Not yet recruiting
CHRU Nancy - hôpitaux de brabois
Vandœuvre-lès-Nancy, 54500
Bruno LEVY, MD, +33383154469, b.levy@chu-nancy.fr
About this study
Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly being used worldwide to treat severe cardiogenic shock. The survival rate of these patients has increased in the last decade, reaching 45-50% for patients with acute myocardial infarction (AMI), the most frequent indication of the technique, 50-60% for patients with end-stage dilated cardiomyopathy bridged to heart transplantation or long-term left ventricle assist device (LVAD) surgery, 60-70% for fulminant myocarditis, while it remains lower for post-cardiotomy cardiogenic shock (25-35%) and after cardiac arrest (20-40%). However, peripherally inserted VA-ECMO increases left ventricular (LV) afterload, that may lead to poorer clinical outcomes by fostering left ventricular distension, blood stagnation, aortic valve closure, all of which increasing pulmonary congestion and the need for mechanical ventilation and compromising myocardial recovery whenever it is possible, or delaying a bridge to a heart transplantation or long-term left ventricle assist device (LVAD) surgery for patients with end-stage cardiac dysfunction. Several methods have been proposed to reduce afterload after VA-ECMO, including the use of an intra-aortic balloon pump (IABP), balloon atrial septostomy, transseptal left atrial cannula insertion, and use of the left-sided Impella device (Abiomed, Danvers, MA, USA). The clinical benefits of left ventricular unloading have been suggested by many retrospective case-control studies, including a study by our group that showed that associating an IABP with peripheral VA-ECMO was independently associated with a lower frequency of hydrostatic pulmonary edema under ECMO and more days off mechanical ventilation. More recently, unloading the left ventricle with an IABP was associated with the best survival rate and security profile as compared to no unloading or unloading with a microaxial pump in 12,734 VA-ECMO patients included in the Extracorporeal Life Support Organization registry. It should also be mentioned that another large registry study showed that the greatest benefit of LV unloading under ECMO was observed with early versus delayed insertion of the unloading device. Lastly, the EARLY-UNLOAD randomized trial in which a transseptal left atrial cannula was used for LV unloading yielded negative results. However, it is important to note that 50% of control patients were rapidly transitioned to LV unloading, thereby compromising the opportunity to demonstrate a mortality benefit. It was also underpowered for the primary outcome of D30 mortality since it included only 116 patients As a result, the recourse to systematic early LV unloading remains highly heterogeneous in clinical practice. For example, , while IABP was EULODIA - Protocol, version 1.0 dated 24/01/2025 Page 6 sur 54 This document is the property of DRCI/AP-HP. All reproduction is strictly prohibited.
Version no. 4.0 of 31/05/2019 associated to ECMO in >70% of the cases in our series of AMI CS patients, only 5.8% of the patients included in the ECMO arm of the recent ECLS-Shock trial received an unloading device, which may have contributed to the neutral result of the study and the only randomized trial to date was underpowered and flawed by a very high rate of early cross-over. Indeed, there is large heterogeneity in current clinical practice, where decisions on whether to add an additional mechanical unloading device during VA-ECMO support vary widely.
Therefore, a new and adequately powered trial comparing systematic early left ventricular unloading to a conventional approach, with rescue left ventricular unloading only in case of clear and urgent indication, i.e. if overt hydrostatic cardiogenic pulmonary edema occurs, is urgently needed. The EULODIA trial is designed to test the hypothesis that early preventive left ventricle unloading with an IABP improves clinical outcomes as compared to conventional care with delayed curative unloading in patients under VA-ECMO for refractory cardiogenic shock.
- Conditions
- Cardiogenic Shock Acute
- Being tested
- Early Left Ventricle unloading
- Keywords
- ECMO, BPIA, Cardiogenic shock acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Left Ventricle unloadingProcedure or surgery
An Intraortic balloon pump will be systematically inserted as soon as possible, within 12 hours post-randomization.
- A pulmonary artery catheter (PAC) will enable hemodynamic monitoring of cardiac filling pressures, cardiac output and pulmonary artery pressures.
- Doppler Echocardiography will be performed at least daily to monitor LV ejection, LV dimension, appearance of LV blood stagnation, aortic time-velocity integral (VTI) and aortic valve opening.
- Escalation to a microaxial LV venting pump, central ECMO or atrial septostomy will be possible and discussed by the Shock team (as suggested by international recommendations) in case of
- Overt cardiogenic pulmonary edema requiring invasive mechanical ventilation
- Persisting more than 6 hours despite IABP support and optimization of patient's management (titration of ECMO blood flow, inotropes, non-invasive mechanical ventilation with PEEP, diuretics or hemofiltration).
| Study group | Role | What they receive |
|---|---|---|
| Early Left Ventricle unloading arm | Experimental | An Intraortic balloon pump will be systematically inserted as soon as possible, within 12 hours post-randomization.
* A pulmonary artery catheter (PAC) will enable hemodynamic monitoring of cardiac filling pressures, cardiac output and pulmonary artery pressures.
* Doppler Echocardiography will be performed at least daily to monitor LV ejection, LV dimension, appearance of LV blood stagnation, aortic time-velocity integral (VTI) and aortic valve opening.
* Escalation to a microaxial LV venting pump, central ECMO or atrial septostomy will be possible and discussed by the Shock team (as suggested by international recommendations) in case of
* Overt cardiogenic pulmonary edema requiring invasive mechanical ventilation
* Persisting more than 6 hours despite IABP support and optimization of patient's management (titration of ECMO blood flow, inotropes, non-invasive mechanical ventilation with PEEP, diuretics or hemofiltration). Receives: Procedure: Early Left Ventricle unloading |
| Standard management of VA-ECMO cardiogenic shock patients. | No intervention | A pulmonary artery catheter will enable hemodynamic monitoring of cardiac filling pressures, cardiac output, and pulmonary artery pressures. - Doppler Echocardiography will be performed at least daily to monitor LV ejection, LV dimension, appearance of LV blood stagnation, aortic VTI and aortic valve opening. - Optimization of patient's management in case of signs of cardiogenic pulmonary edema occurring under VA-ECMO (titration of ECMO blood flow, inotropes, non-invasive ventilation mechanical ventilation with PEEP, diuretics or hemofiltration). - LV unloading (IABP, microaxial LV venting pump, central ECMO or atrial septostomy) (as suggested by international recommendations) discussed by the Shock team in case of overt cardiogenic pulmonary edema persisting more than 6 hours despite the aforementioned measure and the recourse to invasive mechanical ventilation AND o PCWP >20 mmHg OR o Aortic valve opening less than 50% of electric systole and VTI < 4cm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite hierarchical outcome assessed at day 30, composed of three components: 1)All-cause mortality, 2)unloading device or strategy related complication 3) time off temporary mechanical circulatory support (tMCS) or invasive mechanical ventilation (
- Each subject is compared to every other subject and assigned one number resulting from each pair-wise comparison (win +1; lose-1; tie=0) based on whom fared better. Since mortality outcome is clinically more important, mortality takes precedence over complications and days off IMV/tMCS at day 30. If one patient survived at day 30 and the other did not, scores of +1 and -1 will be assigned, respectively. If both patients survived, the assigned score will depend on the second component: if one patient had a complication and the other did not, a score of -1 and +1 will be assigned, respectively. If both patients survived without complication, the assigned score will depend on which patient had more time off t-MCS/IMV: the patient with more time off will receive a score of +1, and the other -1. For each patient, scores for all pairwise comparisons will be summed, resulting in a cumulative score which will be the primary endpoint of the study
Measured: Day 30
Secondary outcomes (23)
Bleeding (BARC 3 or more)
Measured: Day 30
Infection at any MCS insertion site treated by antibiotics
Measured: Day 30
Critical limb ischemia (leading to fasciotomy, surgical or endovascular intervention, MCS withdrawal).
Measured: Day 30
Stroke (ischemic or hemorrhagic)
Measured: Day 30
Any specific complication associated with intraventricular microvascular pump (aortic or mitral valve lesion, severe hemolysis) or atrial septostomy (tamponade, cardiac perforation).
Measured: Day 30
All-cause mortality
Measured: Day 60
Duration of ECMO support
Measured: Day 60
Bridge to durable ventricular assist device (left ventricular assist device type Heartmate3 or a total artificial heart) or heart transplantation
Measured: Day 60
Durations of ICU stay
Measured: Day 60
Number of days of invasive mechanical ventilation
Measured: Day 30
Number of days of renal replacement therapy
Measured: Day 30
Number of days alive without organ failure(s)
Measured: From randomization to day 30
Number of ventilator-associated pneumonia treated with antibiotics
Measured: From randomization to Day 60
Durations of hospitalization
Measured: Day 60
Durations of ICU stay
Measured: Between inclusion and Day 30
Durations of hospitalization
Measured: Between inclusion and Day 30
Major complication specifically related to the unloading device (IABP, microaxial IMPELLA pump) or strategy (atrial septostomy) - Bleeding (BARC 3 or more)
Measured: Between inclusion and Day 30
All cause mortality
Measured: Day 30
Number of days of ECMO support and days free of ECMO support
Measured: Day 30
Delay to overt pulmonary edema (defined by pulmonary capillary wedge pressure (PCWP) >20 mmHg and bilateral infiltrates on Chest X-ray) indicating escalation to an unloading device (IABP, microaxial LV venting pump or atrial septostomy for control group
Measured: Day 30
Rate of bridge to durable ventricular assist device or heart transplantation
Measured: Day 30
Total number of packed red blood cells and platelet transfused
Measured: Day 30
Left ventricular function assessed with Doppler echocardiography for alive patients only
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start13 Mar 2026
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic Shock AcuteStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, prospective, randomized, comparative open trial
- Masking
- None (open label)
- Enrolment
- 298 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume LEBRETON, MD, Study director, Assistance Publique Hôpitaux de Paris - Pitié Salpêtrière HospitalAdrien BOUGLE, MD, Study director, Assistance Publique Hôpitaux de Paris - Pitié Salpêtrière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027202
- Sponsor's protocol ID
- APHP240927
- Other IDs
- IDRCB Number
- Acronym
- EULODIA
- Status last verified
- Apr 2026
- First submitted
- 7 May 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Preventive Left Ventricle Unloading After VA-ECMO for Refractory Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT07027202
- Acronym / sponsor ID
- EULODIA / APHP240927
- Conditions
- Cardiogenic Shock Acute
- Keywords
- ECMO, BPIA, Cardiogenic shock acute
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 298 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly being used worldwide to treat severe cardiogenic shock. The survival rate of these patients has increased in the last decade, reaching 45-50% for patients with acute myocardial infarction (AMI), the most frequent indication of the technique, 50-60% for patients with end-stage dilated cardiomyopathy bridged to heart transplantation or long-term left ventricle assist device (LVAD) surgery, 60-70% for fulminant myocarditis, while it remains lower for post-cardiotomy cardiogenic shock (25-35%) and after cardiac arrest (20-40%). However, peripherally inserted VA-ECMO increases left ventricular (LV) afterload, that may lead to poorer clinical outcomes by fostering left ventricular distension, blood stagnation, aortic valve closure, all of which increasing pulmonary congestion and the need for mechanical ventilation and compromising myocardial recovery whenever it is possible, or delaying a bridge to a heart transplantation or long-term left ventricle assist device (LVAD) surgery for patients with end-stage cardiac dysfunction. Several methods have been proposed to reduce afterload after VA-ECMO, including the use of an intra-aortic balloon pump (IABP), balloon atrial septostomy, transseptal left atrial cannula insertion, and use of the left-sided Impella device (Abiomed, Danvers, MA, USA). The clinical benefits of left ventricular unloading have been suggested by many retrospective case-control studies, including a study by our group that showed that associating an IABP with peripheral VA-ECMO was independently associated with a lower frequency of hydrostatic pulmonary edema under ECMO and more days off mechanical ventilation. More recently, unloading the left ventricle with an IABP was associated with the best survival rate and security profile as compared to no unloading or unloading with a microaxial pump in 12,734 VA-ECMO patients included in the Extracorporeal Life Support Organization registry. It should also be mentioned that another large registry study showed that the greatest benefit of LV unloading under ECMO was observed with early versus delayed insertion of the unloading device. Lastly, the EARLY-UNLOAD randomized trial in which a transseptal left atrial cannula was used for LV unloading yielded negative results. However, it is important to note that 50% of control patients were rapidly transitioned to LV unloading, thereby compromising the opportunity to demonstrate a mortality benefit. It was also underpowered for the primary outcome of D30 mortality since it included only 116 patients As a result, the recourse to systematic early LV unloading remains highly heterogeneous in clinical practice. For example, , while IABP was EULODIA - Protocol, version 1.0 dated 24/01/2025 Page 6 sur 54 This document is the property of DRCI/AP-HP. All reproduction is strictly prohibited.
Version no. 4.0 of 31/05/2019 associated to ECMO in >70% of the cases in our series of AMI CS patients, only 5.8% of the patients included in the ECMO arm of the recent ECLS-Shock trial received an unloading device, which may have contributed to the neutral result of the study and the only randomized trial to date was underpowered and flawed by a very high rate of early cross-over. Indeed, there is large heterogeneity in current clinical practice, where decisions on whether to add an additional mechanical unloading device during VA-ECMO support vary widely.
Therefore, a new and adequately powered trial comparing systematic early left ventricular unloading to a conventional approach, with rescue left ventricular unloading only in case of clear and urgent indication, i.e. if overt hydrostatic cardiogenic pulmonary edema occurs, is urgently needed. The EULODIA trial is designed to test the hypothesis that early preventive left ventricle unloading with an IABP improves clinical outcomes as compared to conventional care with delayed curative unloading in patients under VA-ECMO for refractory cardiogenic shock.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, prospective, randomized, comparative open trial
| Arm | Type | Receives |
|---|---|---|
| Early Left Ventricle unloading arm | Experimental | Procedure: Early Left Ventricle unloadingAn Intraortic balloon pump will be systematically inserted as soon as possible, within 12 hours post-randomization. * A pulmonary artery catheter (PAC) will enable hemodynamic monitoring of cardiac filling pressures, cardiac output and pulmonary artery pressures. * Doppler Echocardiography will be performed at least daily to monitor LV ejection, LV dimension, appearance of LV blood stagnation, aortic time-velocity integral (VTI) and aortic valve opening. * Escalation to a microaxial LV venting pump, central ECMO or atrial septostomy will be possible and discussed by the Shock team (as suggested by international recommendations) in case of * Overt cardiogenic pulmonary edema requiring invasive mechanical ventilation * Persisting more than 6 hours despite IABP support and optimization of patient's management (titration of ECMO blood flow, inotropes, non-invasive mechanical ventilation with PEEP, diuretics or hemofiltration). |
| Standard management of VA-ECMO cardiogenic shock patients. | No intervention | –A pulmonary artery catheter will enable hemodynamic monitoring of cardiac filling pressures, cardiac output, and pulmonary artery pressures. - Doppler Echocardiography will be performed at least daily to monitor LV ejection, LV dimension, appearance of LV blood stagnation, aortic VTI and aortic valve opening. - Optimization of patient's management in case of signs of cardiogenic pulmonary edema occurring under VA-ECMO (titration of ECMO blood flow, inotropes, non-invasive ventilation mechanical ventilation with PEEP, diuretics or hemofiltration). - LV unloading (IABP, microaxial LV venting pump, central ECMO or atrial septostomy) (as suggested by international recommendations) discussed by the Shock team in case of overt cardiogenic pulmonary edema persisting more than 6 hours despite the aforementioned measure and the recourse to invasive mechanical ventilation AND o PCWP >20 mmHg OR o Aortic valve opening less than 50% of electric systole and VTI < 4cm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient on peripheral femoro-femoral VA ECMO for severe Cardiogenic shock for ≤24h
- Initiation of LV unloading possible within 12 hours after randomization.
- 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.
- Social security registration (AME excluded)
Key exclusion criteria (16 listed)
- Age <18 years
- Pregnancy
- Onset of VA-ECMO >24 h
- 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
- ECMO for massive pulmonary embolism or primary RV failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Left Ventricle unloadingAn Intraortic balloon pump will be systematically inserted as soon as possible, within 12 hours post-randomization. * A pulmonary artery catheter (PAC) will enable hemodynamic monitoring of cardiac filling pressures, cardiac output and pulmonary artery pressures. * Doppler Echocardiography will be performed at least daily to monitor LV ejection, LV dimension, appearance of LV blood stagnation, aortic time-velocity integral (VTI) and aortic valve opening. * Escalation to a microaxial LV venting pump, central ECMO or atrial septostomy will be possible and discussed by the Shock team (as suggested by international recommendations) in case of * Overt cardiogenic pulmonary edema requiring invasive mechanical ventilation * Persisting more than 6 hours despite IABP support and optimization of patient's management (titration of ECMO blood flow, inotropes, non-invasive mechanical ventilation with PEEP, diuretics or hemofiltration). | Procedure or surgery | Early Left Ventricle unloading arm |
Primary outcome
Composite hierarchical outcome assessed at day 30, composed of three components: 1)All-cause mortality, 2)unloading device or strategy related complication 3) time off temporary mechanical circulatory support (tMCS) or invasive mechanical ventilation (
Time frame: Day 30
o Each subject is compared to every other subject and assigned one number resulting from each pair-wise comparison (win +1; lose-1; tie=0) based on whom fared better. Since mortality outcome is clinically more important, mortality takes precedence over complications and days off IMV/tMCS at day 30. If one patient survived at day 30 and the other did not, scores of +1 and -1 will be assigned, respectively. If both patients survived, the assigned score will depend on the second component: if one patient had a complication and the other did not, a score of -1 and +1 will be assigned, respectively. If both patients survived without complication, the assigned score will depend on which patient had more time off t-MCS/IMV: the patient with more time off will receive a score of +1, and the other -1. For each patient, scores for all pairwise comparisons will be summed, resulting in a cumulative score which will be the primary endpoint of the study
23 secondary outcomes
Bleeding (BARC 3 or more)
Time frame: Day 30
Infection at any MCS insertion site treated by antibiotics
Time frame: Day 30
Critical limb ischemia (leading to fasciotomy, surgical or endovascular intervention, MCS withdrawal).
Time frame: Day 30
Stroke (ischemic or hemorrhagic)
Time frame: Day 30
Any specific complication associated with intraventricular microvascular pump (aortic or mitral valve lesion, severe hemolysis) or atrial septostomy (tamponade, cardiac perforation).
Time frame: Day 30
All-cause mortality
Time frame: Day 60
Duration of ECMO support
Time frame: Day 60
Bridge to durable ventricular assist device (left ventricular assist device type Heartmate3 or a total artificial heart) or heart transplantation
Time frame: Day 60
Durations of ICU stay
Time frame: Day 60
Number of days of invasive mechanical ventilation
Time frame: Day 30
Number of days of renal replacement therapy
Time frame: Day 30
Number of days alive without organ failure(s)
Time frame: From randomization to day 30
Number of ventilator-associated pneumonia treated with antibiotics
Time frame: From randomization to Day 60
Durations of hospitalization
Time frame: Day 60
Durations of ICU stay
Time frame: Between inclusion and Day 30
Durations of hospitalization
Time frame: Between inclusion and Day 30
Major complication specifically related to the unloading device (IABP, microaxial IMPELLA pump) or strategy (atrial septostomy) - Bleeding (BARC 3 or more)
Time frame: Between inclusion and Day 30
All cause mortality
Time frame: Day 30
Number of days of ECMO support and days free of ECMO support
Time frame: Day 30
Delay to overt pulmonary edema (defined by pulmonary capillary wedge pressure (PCWP) >20 mmHg and bilateral infiltrates on Chest X-ray) indicating escalation to an unloading device (IABP, microaxial LV venting pump or atrial septostomy for control group
Time frame: Day 30
Rate of bridge to durable ventricular assist device or heart transplantation
Time frame: Day 30
Total number of packed red blood cells and platelet transfused
Time frame: Day 30
Left ventricular function assessed with Doppler echocardiography for alive patients only
Time frame: Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillaume LEBRETON, MD study director
Assistance Publique Hôpitaux de Paris - Pitié Salpêtrière Hospital
Adrien BOUGLE, MD study director
Assistance Publique Hôpitaux de Paris - Pitié Salpêtrière Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Left Ventricle unloading in people with Cardiogenic Shock Acute, run by Assistance Publique - Hôpitaux de Paris at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alain COMBES, MD (0142163818, alain.combes@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite hierarchical outcome assessed at day 30, composed of three components: 1)All-cause mortality, 2)unloading device or strategy related complication 3) time off temporary mechanical circulatory support (tMCS) or invasive mechanical ventilation ( (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.