Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT07027202
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07027202
Study Brief:
Protocol Section:
NCT07027202