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New treatment option for Cardiogenic Shock Acute
Official title Early Preventive Left Ventricle Unloading After VA-ECMO for Refractory Cardiogenic Shock
ClinicalTrials.gov ID: NCT07027202
What this study is testing
- What it's testing
- 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%).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 assigned by chance according to the...
- Social security registration (AME excluded)
You likely can't join if
- 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...
- ECMO for massive pulmonary embolism or primary RV failure
- ECMO after heart transplant
See the full eligibility criteria
- 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 assigned by chance according to the specifications of emergency consent and the patient will be asked to...
- Social security registration (AME excluded)
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Clermont-Ferrand, France
- Créteil, France
- Lille, France
- Paris, France
- Rennes, France
- Strasbourg, France
- Toulouse, France
- Vandœuvre-lès-Nancy, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clermont-Ferrand, France; Créteil, France; Lille, France; Paris, France; Rennes, France; Strasbourg, France and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.