Comparing VA ECMO with and without left ventricular unloading in cardiogenic shock patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effects of adding left ventricular unloading to veno-arterial extracorporeal membrane oxygenation (VA ECMO) in patients experiencing cardiogenic shock. Participants will be randomized to receive either standard VA ECMO or VA ECMO combined with an intra-aortic balloon pump (IABP) for LV unloading. The study will assess physiological changes, myocardial function, and recovery outcomes through various measurements, including lab work and echocardiography. The goal is to determine if LV unloading improves patient outcomes compared to VA ECMO alone.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients (age 18 years or older)
* Diagnosis of acute cardiogenic shock (CS)
* Patients failing medical therapy, defined as 1 or more of the following:

  1. Society for Coronary Angiography and Interventions (SCAI) Stage C or greater
  2. 2 or more inotropic medications and not improving
  3. IABP in place and clinically worsening
  4. Placed on VA ECMO for CS
  5. In the opinion of the attending physician, patient has worsening CS and could require VA ECMO support in the near-term

Exclusion Criteria:

* Metastatic or stage 4 cancer
* Atrial septostomy
* Planned LV unloading on ECMO
* Anticipated death \<72 hours
* Existing durable left ventricular assist device (dLVAD)
* Unwillingness to randomize
* Patients who are pregnant

Where it's running

• University of Utah
  Salt Lake City, Utah, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.