Comparing Impella and IABP for heart support in cardiogenic shock
Early Left Ventricular unLoading by Impella (ECMELLA) or Intra-aortic Balloon Pump for Cardiogenic Shock in Patients on VA-ECMO
University Hospital, Montpellier · NCT06645990
This study is testing whether using Impella or an intra-aortic balloon pump helps adults with severe heart failure and cardiogenic shock feel better when they are also on ECMO support.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier (other) |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT06645990 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of early left ventricular unloading using Impella and intra-aortic balloon pump (IABP) devices in patients experiencing cardiogenic shock who are also supported by ECMO. The study will analyze data from adult patients admitted for cardiogenic shock between 2010 and 2023, focusing on the potential benefits and complications associated with these mechanical support devices. By comparing these two approaches, the study seeks to provide insights into the best strategies for managing patients with severe heart failure.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are experiencing cardiogenic shock and are supported by ECMO along with either Impella or IABP.
Not a fit: Patients who are moribund, have severe chronic cardiomyopathy, or are undergoing ongoing eCPR are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with cardiogenic shock, potentially enhancing recovery and survival rates.
How similar studies have performed: While there have been studies on mechanical support devices, this specific comparison of Impella and IABP in the context of ECMO for cardiogenic shock is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (more than or =18 years) admitted for cardiogenic shock supported by ECMO+ IABP or ECMELLA between January 1, 2010, and December 31, 2023 Exclusion Criteria: * Ongoing extra-corporeal CardioPulmonary Resuscitation (eCPR) at time of ECMO implantation * Cardiogenic shock with previous prolonged continuous cardiopulmonary resuscitation (CPR) more than 30 minutes * Acute irreversible neurological injury * Previous known severe chronic cardiomyopathy (LVEF less than 25%) or awaiting heart transplantation or LVAD implantation * Contraindication to the implantation of an Impella or IABP * Mechanical complications of myocardial infarction * Moribund patient (SAPS more than 90) * Previous known severe chronic renal or hepatic failure * Age less than18 years
Where this trial is running
Montpellier
- CHU Arnaud de Villeneuve — Montpellier, France (RECRUITING)
Study contacts
- Principal investigator: Aurore UGHETTO, MD — Montpellier University Hospital, France
- Study coordinator: Aurore UGHETTO, MD
- Email: a-ughetto@chu-montpellier.fr
- Phone: 0033622054893
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiogenic Shock, ECMO, ECLS, Impella, IABP, pVAD, mortality